Clinical trial NCT01977937
Conditions: Pain, Postoperative
Keywords: gabapentin Analgesic Drugs Analgesics, Nonopioid
Sponsor: Oregon Health and Science University
Start date: 2013-11-01; Completion date: 2018-04-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the patient experience when using gabapentin with other pain control medications after posterior spinal fusion surgery for scoliosis in adolescents. These results will be compared to patients who underwent the same procedure during the study period and received the same standardized pain control regimen excluding gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side effects including nausea, sedation and urinary retention (inability to empty one's bladder) will also be recorded.The null hypotheses are as follows:

1. There is no significant difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.
2. There is no significant difference in the amount of opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.

Detailed description:
Patients aged 10-19 years with idiopathic scoliosis, and classified as American Society of Anesthesiology (ASA) class I to III who intended to undergo posterior spinal fusion for deformity correction were enrolled. Prior to surgery, subjects were randomized into either the experimental or control group by the OHSU research pharmacy using an online randomization tool, which utilized block randomization upon patient enrollment to result in equal sized groups at study completion. Patients, caretakers and providers remained blinded to the group assignments.

Patients filled out the Scoliosis Research Society, SRS-22 standardized form at a pre-operative clinic appointment. Following hospital admission, patients recorded initial pain level with the Visual Analog Scale (VAS) prior to receiving standardized pre-operative medications. The VAS scale used in this study was a 10 cm line with anchors of "no pain" at the left and "worst pain imaginable" at the right; each point was measured to the nearest millimeter. In the post-operative period, nursing staff assessed patient pain using the VAS at 4-hour intervals from 06:00 until 22:00 for the duration of hospitalization for a minimum of 4 daily scores recorded per patient. After the third post-operative day, but before discharge, the parent or guardian of each subject was asked to complete an IRB-approved survey to measure parent demographics and parental satisfaction with the patient's hospitalization and pain control.

Each patient received standardized medications according to our multimodal pain protocol. Following hospital admission, patients in both groups received one 12.5 mg/kg dose of intravenous (IV) acetaminophen. Patients in the experimental group received one 15 mg/kg dose of liquid gabapentin while the control group received a placebo, formulated to match the volume, color, taste, and smell of the experimental medication. The gabapentin or placebo was prepared by the OHSU research pharmacists so that providers and investigators remained blinded to treatment assignment. Several intraoperative anesthetic medications were given to subjects in both groups including: IV ketamine at 5mcg/kg/min for 120 minutes and IV Ketorolac 0.5mg/kg up to 15mg. Intra-operative IV propofol and IV hydromorphone were titrated to desired effect.In the post-operative period, gabapentin was administered to the experimental group at 10mg/kg PO q8h, beginning at Phase II and continued through postoperative day four. The control group received equivalent volume doses of placebo at the same intervals. Post-operative medication was administered according to the following protocol for both groups: ketorolac continued at 0.5mg/kg up to 15mg IV q6h for 12 total doses. Once ketorolac doses were complete, the patient may have received Ibuprofen 10mg/kg up to 600mg PO as needed. Hydromorphone was given through patient-controlled analgesia (PCA) at a basal dose of 0.002mg/kg/hr for 24 hours and demand dose of 0.004mg/kg with an 8-minute lockout. Once basal PCA was discontinued, administration of oxycodone 0.1-0.2mg/kg PO up to 15mg PO q4h as needed supplemented the PCA demand dose. If the patient tolerated PO oxycodone without emesis, the PCA hydromorphone was discontinued after 24 hours, but a rescue dose of hydromorphone 0.002mg IV q4 was available if needed. Other as needed medications included diazepam 0.15mg/kg up to 5mg PO q6h for muscle spasms, ondansetron 0.1mg/kg up to 4mg IV q12h for nausea, and IV acetaminophen 12.5mg/kg up to 1000mg q6h. Acetaminophen 12.5mg/kg up to 650mg PO q6h hours was administered after the IV was removed. All patients received one Senokot-S tablet and Miralax 0.8 g/kg up to 17g daily for bowel regimen.

For the entire hospitalization, nursing staff monitored vital signs and assessed sedation using the standardized Pasero Opioid-induced Sedation Scale (POSS) protocols at 4-hour intervals.16 Any POSS score of 3 or greater resulted in more frequent monitoring of respiratory status and sedation level, decreased opioid dosing, and administration of naloxone as needed. All patients were routinely monitored for known adverse gabapentin drug reactions including: peripheral edema, nausea/emesis, viral disease, ataxia, dizziness, nystagmus, somnolence, hostile behavior, fatigue and fever, Stevens-Johnson syndrome, drug hypersensitivity reactions, drug induced coma/seizure, and suicidal thoughts. Any perceived adverse reaction would have resulted in the gabapentin or placebo being stopped at the clinicians' discretion

Arms: arm 1: Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital. arm 2: Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.
Interventions: intervention 1: Gabapentin 250mg/5mL NDC:59762-5025-01 intervention 2: Simple Syrup
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
Protocol Title: Pain Control in Pediatric Posterior Spine 
Fusion Patients: The Effect of Gabapentin on Post-
operative Opioid Use and Patient Satisfaction 
 
 
 
 
 
 
 
 
 
Principle Investigator: Matthew F. Halsey, MD 
Document Approval Date: July 18, 2018 
NCT#: 01977937 


Project Title: Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-
operative Opioid Use and Patient Satisfaction. 
Primary Investigator: Matthew F. Halsey, MD  
Primary Aims:  
To evaluate the pain control efficacy of gabapentin when added to a standard postoperative protocol in 
pediatric patients undergoing posterior spinal fusion for idiopathic or neurogenic scoliosis, using the 
visual analog scale (VAS - Appendix 1) and total dose/kg of opioid used during the postoperative period 
to determine differences in pain. 
Secondary Aims: 
To evaluate the effects of adding gabapentin on instances of opiate related side effects, duration of 
hospitalization, the amount of narcotics used postoperatively and overall family satisfaction with efforts 
to control postoperative pain. 
Introduction:  
Surgery for the correction of pediatric spine deformity results in significant post-operative pain 
that is challenging to the patients, their families and the staff caring for them. Numerous studies have 
tried to identify the best methods to control this pain including the use of opioid PCA, intravenous 
acetaminophen, epidural morphine, intravenous ketorolac and multimodal therapies. 1,2,3,4,5 These 
efforts have produced some successes yet there remain problems with poorly controlled pain and 
substantial adverse effects associated with each of these modalities. 
Recently, attention has turned to the use of gabapentin as a potential agent to improve peri-
operative pain control and to decrease the use of opioids.6 Originally used as an anticonvulsant 
medication, gabapentin is now commonly used to treat chronic, centrally-mediated neuropathic pain 
syndromes.8 It’s mechanism of action is to suppress spontaneous central neuronal firing thereby 
decreasing the pain associated with the central sensitization brought about by the peripheral tissue 
injury.7 
The impetus for this study is to re-evaluate the effectiveness of gabapentin in a randomized, 
double-blinded, controlled fashion similar to that used by Rusy et al8 but in the context of a more robust 
multi-modal postoperative pain management milieu.   
Methods: 
This will be a prospective, randomized, controlled and double-blinded study. Study candidates 
will be identified in clinical encounters which evaluate or diagnose idiopathic or neurogenic scoliosis in 
patients aged 10-19. Written, informed assent from each patient and consent from parents will be 
obtained at pre-operative visits in which posterior spinal fusion is the planned procedure. Inclusion 
criteria will be patients of age 10-19 with an ASA patient classification of I to III. Patients will be excluded 


from the study if they have a body mass index greater than or equal to 35.0,  will require a surgical 
approach or technique differing from posterior spinal fusion, and/or have allergies to any of the 
standardized or experimental study medications: acetaminophen, gabapentin, hydromorphone, 
ketorolac or oxycodone. Patients who cannot effectively use the PCA alone will be included in the study 
for analysis but will not be counted towards the calculated number of patients per study arm due to 
difficulty comparing their hydromorphone use with that of other patients. Many of these patients are 
projected to be neuromuscular patients, and to build on a relative parity of literature about post-
operative pain control in neuromuscular scoliosis RNCA will be used and all data recorded as with 
patients who can communicate their pain level.  
If patients choose to participate in the study, they will be randomized into either the 
experimental or control group using the following computer randomization applet: 
<www1.assumption.edu/users/avadum/applets/applets.html> 
Patients, caretakers and providers will be blinded to the group assignments. An electronic copy of the 
group assignments will be retained by researchers uninvolved in patient care, and patients will be 
known by an alphanumeric code in research files to maintain privacy of information. 
 
Medications and Patient Care Protocols: 
 
Following pre-operative hospital admission, all patients will be asked to record their initial pain 
level with the VAS tool prior to receiving standardized pre-operative medications. The VAS has been well 
verified in pediatric patients as a valid pain measure patients are capable of understanding and using 
reliably. Patients in both groups will receive one 12.5 mg/kg dose of IV acetaminophen. Additionally, 
patients in the experimental group will receive one 15 mg/kg dose of gabapentin while the control 
group will receive a placebo. Each time the gabapentin or placebo is administered it will be prepared by 
the OHSU research pharmacists so that providers will remain blinded to treatment assignment. These 
medications will be administered on a regimen so that each group and patient receive them 
approximately the same amount of time prior to surgery.  The placebo will be compounded by the 
research pharmacy and both the gabapentin and placebo will be in liquid form.   
 
Several intraoperative anesthetic medications will be protocolized including IV ketamine at 
5mcg/kg/min for 120 minutes and IV Ketorolac 0.5mg/kg up to 15mg(at the conclusion of the case), 
while propofol infusions and IV hydromorphone are titrated to desired effect.   Two surgeons, Dr. 
Matthew Halsey MD and Dr. Ronald Turker MD will perform all of the surgeries in this study, and all 
patients considered in this study will undergo a posterior spinal fusion procedure.  
 
Post-operative medication administration will also be protocolized.  Ketorolac will be continued at 
0.5mg/kg up to 15mg IV q6 for twelve total doses (including the intraoperative dose).  Once the 
Ketorolac doses are complete, the patient will receive Ibuprofen 10mg/kg up to 600mg PO q6 
scheduled. Hydromorphone PCA will be set at a basal dose of 0.002mg/kg/hr and demand dose of 
0.004mg/kg with an 8 minute lockout; the basal PCA dose will be administered for 24 hours. Once basal 
PCA is discontinued, administration of oxycodone 0.1-0.2mg/kg PO up to 15mg PO q4h as needed will be 


used in conjunction with the PCA demand dose. If the patient is able to tolerate PO oxycodone without 
emesis, after 24 hours the PCA will be completely removed but a rescue dose of Hydromorphone 
0.002mg IV q4 prn will remain.  Other as needed medications will include Valium 0.15mg/kg up to 5mg 
PO q6h for muscle spasms, Ondansetron  0.1mg/kg up to 4mg IV q12h for nausea, and IV 
Acetaminophen 12.5mg/kg up to 1000mg q6h.  Acetaminophen 12.5mg/kg up to 650mg PO q6 hours 
will be administered after the patient’s IV is removed. All patients will receive 1 Senokot-S tablet and 
Miralax 0.8 g/kg up to 17g daily for bowel regimen.   
 
 
The dosing for Gabapentin, the study medication, is 10mg/kg PO q8h, beginning when the patient is 
admitted to his or her floor bed postoperatively.  This will be administered through postoperative day 
four.  Patients in the control group will receive equivolume doses of a placebo medication at the same 
administration intervals.   
 
For the entirety of hospitalization, nursing staff will regularly assess and monitor vital signs and 
POSS sedation using current protocols to ensure patient comfort and safety (POSS tool- Appendix 2).9 
Any POSS score of 3 or greater will be considered unacceptable and require specific actions including but 
not limited to closely monitoring respiratory status, sedation level, decreasing opioid dose, and 
administering naloxone. All rounding residents and doctors will have a checklist of the most common 
and most adverse gabapentin drug reactions when assessing patients. The most common reactions 
include peripheral edema, nausea/vomiting, viral disease, ataxia, dizziness, nystagmus, somnolence, 
hostile behavior, fatigue and fever. The most adverse reactions include Stevens-Johnson syndrome, drug 
hypersensitivity reactions, drug induced coma/seizure, and suicidal thoughts. These reactions will result 
in the gabapentin or placebo being stopped at the clinicians’ discretion. Nursing staff will also assess 
patient pain using the VAS, instructing patients to mark the laminated scale with a vertical line using a 
dry-erase market at the point which best corresponds to their pain level at that time. Nursing staff will 
be instructed on proper measurement, in millimeters from 0, or “no pain,” and will record the measured 
pain score in the patient’s electronic medical record. The VAS scale used in this study is a 10 cm line with 
anchors of “no pain” and “worst pain imaginable.”  The use of a VAS scale in pediatric pain management 
has been well verified.10,11,12,13 The assessment of pain level will be performed a minimum of once per 4 
hour period from 06:00 until 22:00 for the duration of hospitalization and recorded as the highest VAS 
score during each 4 hour period (6-10, 10-14, 14-18, 18-22). A minimum of 4 daily VAS score values will 
be recorded per patient.  
Patients will be discharged from the hospital upon meeting the following criteria: adequate PO 
intake, Foley catheter removal without urinary retention, ability to perform independent bed to toilet 
transfer and adequate pain control on oral medications defined as acceptable to the patient and family. 
(Upon discharge patients will be prescribed oral narcotics which will be counted at their first follow up 
appointment two weeks later.) 
Data Recording: 
 


 
VAS scores will be collected by nursing staff as described above. These laminated sheets will be 
kept with the patients’ charts. A nurse or doctor will also provide the parent or primary caregiver of 
each patient with a pain control satisfaction survey (Appendix 3) on the day of discharge to assess their 
overall understanding and satisfaction with the pain control efforts and efficacy in the hospital. These 
surveys will be collected prior to discharge and also kept with the patient chart. Documents will be 
collected daily by researchers and stored in a secure office on OHSU campus, in a building separate from 
any in which study patients will be receiving care. Upon discharge, all paper documents will be scanned 
into an electronic file. 
 
 
Each patient will have their own individual file kept on OHSU campus computers in the OHSU 
secured network with password permissions applied so that only study researchers have access to the 
information. All medication data will be obtained post-discharge by a review of the electronic 
medication administration report (MAR). PCA hydromorphone syringes used and syringes wasted will be 
counted and recorded. Patient weight, date of transition to oral pain medications, dates of admission, 
operation and discharge, episodes of documented nausea/emesis, instances of urinary retention 
requiring replacement of a catheter after removal or POSS ≥3 recorded in flow sheets will all also be 
retrieved from patients’ electronic medical records by study researchers uninvolved in patient care. VAS 
scores measured in millimeters from the start point and uploaded into electronic medical records by 
nursing staff will be collected. Furthermore, patients will be asked to bring their prescribed 
postoperative outpatient narcotics to their first follow up appointment after discharge for a pill count to 
determine the amount of medication used, and that count will conclude their participation in the study. 
Further follow up appointment data will not be collected. A data collection tool (Appendix 4) has been 
created to record study data in each patient’s electronic study file, and as mentioned above all patients 
will have an alphanumeric code assigned to their information instead of name for data analysis. 
 
Statistical Considerations and Analysis: 
 
Sample size (n) was calculated using a two-sided continuous outcome superiority trial model; n 
= f(α/2, β) × 2 × σ2 / (μ1 − μ2)2 where μ1 and μ2 are the mean outcome in the control and experimental 
group respectively, σ is the standard deviation; f(α, β) = [Φ-1(α) + Φ-1(β)]2; Φ-1 is the cumulative 
distribution function of a standardized normal deviation. Data will be collected for a minimum of a total 
of 50 total patients, with an equal number of patients in both the control and trial groups. Based on past 
history at OHSU Doernbecher Children’s Hospital and the number of annual operative scoliosis cases of 
the two participating surgeons it is estimated that it will take approximately 2 years to accumulate this 
number of study subjects. This n was reached by calculating a statistical study power β of 0.8 and α of 
0.05. The study has been powered to compare VAS scores, mg/kg of opiate use, and duration of 
hospitalization post-operatively.  
 
Calculations were designed to detect a difference in mean VAS score (μ1 − μ2)2 of 2 between 
study groups with a standard deviation σ of 2.5, which was calculated from the standard deviations in 
VAS score reported by Rusy et al.8 These values were chosen to reflect a clinically significant difference 


in pain. Prior studies have stated that variability of 12mm or less constitutes no clinical difference in 
patient pain, and that reduction in pain level of 20% correlates with mild improvement or minimal 
clinically important difference and 30% with notable improvement of patient pain. 12,14 It has also been 
documented that requests and use of additional analgesia increase as patients move through different 
stratifications of pain scores, with those having a score under 30mm rarely requesting additional 
medication and those with a score above 70mm requesting additional pain medication frequently.15 
Instances of severe pain, defined as a pain score of greater than 70mm will be recorded and compared 
between groups as well.  
 
The sample size of 55  patients was confirmed as a valid choice for this study using a continuous 
equivalence calculation to exclude a difference of VAS means of greater than 2.1 with a standard 
deviation of 2.5, β of 0.8 and α of 0.05. Additionally, calculations were performed to power the study for 
amount of opiate used. Provided a sample size of 25 patients per group, β of 0.8, α of 0.05, and standard 
deviation of .0046 mg/kg/h of hydromorphone used based on morphine equivalents using a conversion 
factor of 6.67 as in a prior study by Dampier et al16 this study will be able to detect a significant 
difference in hydromorphone use of .0037 mg/kg/h. Standard deviation estimates were used based on 
data from Rusy et al8 and Turan et al17 and morphine equivalents used to compare to those studies’ 
findings regarding the total daily opioid sparing effects of gabapentin and the significance of a 
cumulative decrease in morphine use after spinal surgery.   
 
The following previously developed and tested study power calculators were used:  
<http://www.sealedenvelope.com/power/continuous-superiority/>  
<http://www.sealedenvelope.com/power/continuous-equivalence/>  
 
Paired T-tests will be used to evaluate the study outcomes and hypotheses. The null hypotheses are as 
follows:  
1. There is no significant difference in pain control when adding gabapentin to a multimodal 
pain management protocol in pediatric post-operative posterior spinal fusion patients. 
 
2. There is no significant difference in the amount of opiate medication required for pain 
control in pediatric post-operative posterior spinal fusion patients.  
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
Appendix 1: VAS 
Visual Analog Pain Scale 
 
 
 
 
 
 
 
 
 
 
What does your pain feel like? 
 
                  No Pain                            
 
 
 
 
 
       Worst Pain 
 
 
 
 
 
 
 
 
 
 
       Imaginable 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Appendix 2: POSS 
Pasero Opioid‐induced Sedation Scale (POSS) 
S = Sleep, easy to arouse 
Acceptable; no action necessary; may increase opioid dose if needed 
 
1. Awake and alert 
Acceptable; no action necessary; may increase opioid dose if needed 
 
2. Slightly drowsy, easily aroused 
Acceptable; no action necessary; may increase opioid dose if needed 
 
3. Frequently drowsy, arousable, drifts off to sleep during conversation 
Unacceptable; monitor respiratory status and sedation level closely until sedation level is stable 
at less than 3 and respiratory status is satisfactory; decrease opioid dose 25% to 50% or notify 
prescriber or anesthesiologist for orders; consider administering a non‐sedating, opioid‐sparing 
non-opioid, such as acetaminophen or an NSAID, if not contraindicated. 
 
4. Somnolent, minimal or no response to verbal or physical stimulation 
Unacceptable; stop opioid; consider administering naloxone; notify prescriber or 
anesthesiologist; monitor respiratory status and sedation level closely until sedation level is 
stable at less than 3 and respiratory status is satisfactory. 
 
*Appropriate action is given in italics at each level of sedation. 
1Opioid analgesic orders or a hospital protocol should include the expectation that a nurse will 
decrease the opioid dose if a patient is excessively sedated. 
2For example, the physician, nurse practitioner, advanced practice nurse, or physician 
assistant responsible for the pain management prescription. 
3Mix 0.4 mg of naloxone and 10 mL of normal saline in syringe and administer this dilute 
solution very slowly (0.5 mL over 2 minutes) while observing the patient’s response (titrate to 
effect) (Source for naloxone administration: Pasero, Portenoy, McCaffery M. Opioid 
analgesics, in Pain: Clinical Manual [ed 2]. St. Louis, MO, Mosby 1999, p. 267; American Pain 
Society [APS]. Principles of Analgesic Use in the Treatment of Acute Pain and Chronic 
Cancer Pain [ed 5], Glenview, IL, APS, 2003.) 
4Hospital protocols should include the expectation that a nurse will administer naloxone to any 
patient suspected of having life-threatening opioid-induced sedation and respiratory 
depression. 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
Appendix 3:   Parental Pain Perception Assessment Survey 
Study #____________  
Interview Date____________ 
 
Surgery Date____________ 
PARENT INFORMATION 
Sex:          Male □     Female □                      Age in years: 16-25 □   26-30 □   31-39 □ 
                                                                               40-49 □   50-59 □   60-69 □ 
Race/Ethnicity: Black □   White □   Hispanic □   Other □ 
Highest Level of Education:   Less than high school □   High school/GED □   Some college  □                         
College graduate □   Advanced Degree □ 
Marital Status:   Single □   Married □   Divorced □   Partnered □   Widowed □  
Relationship to Child:   Mother □   Father □   Stepmother □   Stepfather □   Grandparent □    
                                          Foster parent □   Other □ 
Child’s Health Status:   Excellent □   Very Good □   Good □   Fair □   Poor □ 
Does your child have any disabilities? 
 
 
ADMISSION 
 
The following questions apply to when your child was admitted to the hospital 
Was your child in pain when admitted to the hospital?   Yes □     No □ 
On admission, did your nurse ask you or a family member about how your child shows pain?    
                                                                                                    Yes □     No □ 
Does your child have a history of chronic pain?   Yes □     No □ 
PAIN HISTORY 
 
The following questions apply to previous hospitalizations 
Has your child been hospitalized before?   Yes □     No □ 
If yes, did your child experience pain during the hospitalization?   Yes □     No □ 
     Was the pain related to a procedure?   Yes □     No □ 
     Was the pain following surgery?   Yes □     No □ 
     During that hospitalization, how satisfied were you with your child’s pain control? 
     Very dissatisfied □     Somewhat dissatisfied □     Somewhat satisfied □     Very satisfied □ 
PARENTAL PRESENCE 
 
The following questions apply to this hospitalization 
During the past 24 hours, have you been able to be with your child… 
None of the time □   Some of the time □   Half of the time □   Most of the time □   All of the time □ 


During the past 24 hours, if you were able to be with your child was it… 
During the day □    During the evening □   During the night □   All □ 
 
 
CURRENT PAIN HISTORY 
 
The following questions are general questions related to pain during the hospitalization. 
How often did your child have pain in the past 24 hours? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
On a scale of 0-10, zero meaning no pain and 10 meaning the worst pain imaginable, how often did your 
child experience a pain score of 4 or greater (this is considered moderate to severe pain)? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did the nurse promptly identify that your child was in pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did your child receive pain medication? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
From your perspective, what type of pain medication did your child receive? 
                Pain Pump □        IV Medication □     Oral Medication □      Other  □ 
How often was the pain relieved with the medication? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did someone discuss different options to treat the pain when your child had pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did you receive enough information to understand the pain treatment plan? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often were you or a family member included in decisions to change treatment of your child’s pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often was there a prompt response to your worries or concerns regarding your child’s pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often was there prompt treatment of your child’s pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did the nurse help calm and soothe your child using methods other than pain medication or 
involve child services? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did the nurse demonstrate caring behaviors to help you and your child with their pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did the nurse show they had adequate knowledge and skills to help your child with their 
pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did someone explain the pain relief plan when your child had pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often did someone take the time to answer all your questions about treating pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 


 
What information would you have liked to receive or not receive? 
 
 
 
 
How often were you or a family member included in decisions on how best to treat your child’s pain? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
How often was management of your child’s pain to your satisfaction? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
SATISFACTION 
 
The following questions relate to your level of satisfaction with pain management and any 
recommendations for improvement.  
In the past 24 hours, how often were you satisfied with the providers’ communication with you? 
     None of the time □    Some of the time □    Most of the time □    All of the time □ 
For the past 24 hours, how satisfied are you with the overall management of your child’s pain? 
     Very dissatisfied □    Somewhat dissatisfied □   Somewhat satisfied □    Very satisfied □ 
Overall, how satisfied were you with pain control in the hospital?  
     Very dissatisfied □    Somewhat dissatisfied □   Somewhat satisfied □    Very satisfied □ 
Is there something we could have done differently to better manage your child’s pain? 
 
 
 
 
 
Other comments: 
 
 
 
 
 
 
 
 
 
Thank you for your participation! 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
Appendix 4: Data Collection Tool 
 
 
 
 
 
 


 
                                                          
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1 Milbrandt TA, Singhal M, Minter C, et al: A comparison of three methods of pain control for posterior spinal fusions in 
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938. 
 

ICF_000.pdf: 
Page 1 of 7
IRB#: 9681
MED. REC. NO. _____
NAME
_____
BIRTHDATE
_____
Clinical Research Consent Summary
You are being asked to join a research study. You do not have to join the study.  Even if you 
decide to join now, you can change your mind later.
If you decide to join, you will be asked to sign a consent form, which shows you give permission 
to be in the study, and an authorization form, which shows you give permission for us to use 
and disclose (release) your health information for the study.
1.
The purpose of this study is to learn more about pain control after surgery performed for
scoliosis.
2.
In this study, we will learn about a drug called gabapentin.  Gabapentin will be called
“the study drug” throughout this form.  We want to learn
a.
If using the study drug decreases the amount of pain felt by the subject after
scoliosis surgery;
b.
If using the study drug decreases the amount of narcotic medication needed to
control pain after scoliosis surgery;
c.
If using the study drug improves the satisfaction of the family regarding pain
control;
d.
If the study drug is safe; and
e.
What side effects, if any, are caused by the study drug.
3.
We do not know if the study drug works.
4.
The study drug has not been approved by the Food and Drug Administration (FDA) for
this particular indication.
5.
The study drug is a tablet taken just prior to surgery and then every eight hours for the
four days after surgery.
6.
You will have a 50/50 chance of receiving the study drug vs. a placebo.  A placebo is a
pill that looks like the study drug but has no real medicine in it.  You will not know which
one you get.
7.
If you join the study you will receive the study drug for 4 days, including just prior to your
surgery. We will continue to track opioid usage, pain scale ratings, and sedation ratings
during your entire time in the hospital. You will be asked to complete a survey at the time
of discharge to evaluate your satisfaction with control of pain after surgery.
8.
There are risks involved in participating in the study, some of which may be very serious.
These risks include allergic reaction, emotional instability, hostility, confusion, and
restlessness. Gabapentin may also cause temporary dizziness, sleepiness, and other
symptoms and signs of decreased consciousness. Other potential risks are listed below.
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 2 of 7
IRB#: 9681
MED. REC. NO. _____
NAME
_____
BIRTHDATE
_____
Clinical Research Consent and Authorization Form
TITLE: Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on 
Post-operative Opioid Use and Patient Satisfaction
PRINCIPAL INVESTIGATOR:
CO-INVESTIGATORS:
PURPOSE:
“You” means you or your child in this consent form.  
You have been invited to be in this research study because you are going to have surgery for 
scoliosis. The purpose of this study is to learn if gabapentin reduces the pain of surgery and 
decreases the amount of narcotic medication needed after surgery to control post-operative 
pain.  
Gabapentin will be called “the study drug” throughout this form.
By decreasing the amount of narcotic medication needed to control pain after spine surgery the 
study drug may decrease the narcotic-associated side effects after spine surgery such as 
nausea, vomiting, inability to urinate and constipation. It may also decrease the overall amount 
of pain experienced after surgery for scoliosis. 
Right now, the study drug is not approved for use for post-operative pain management after 
spine surgery in the United States because we do not know enough about it.
This study will require no extra visits to the clinic and will be completed during your admission 
for scoliosis surgery.
Fifty-five subjects will be enrolled in this study at OHSU.
PROCEDURES:
You will be asked about participating in the study either at the time you are indicated for 
scoliosis surgery in the office or on the day of surgery. This discussion can take up to one-half 
hour.
This is a randomized study.  Neither you nor the investigator can choose whether you get 
gabapentin or the placebo. A placebo is a pill that looks like the study drug but has no real 
medicine in it. Half of the subjects in this study will get the placebo.
You and the investigators will not know which pill you are taking.  The study is done this way 
because knowing whether you are getting the study drug can change the results of the study.  If 
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 3 of 7
you start having serious side effects from the study drug, the investigators can find out what you 
are taking in order to help you.  Please ask the investigator if you have any questions at all 
about this kind of study. 
Once you have agreed to participate in the study you will be assigned to one of two groups, the 
study drug group or the placebo group. 
Just prior to surgery you will receive the study drug or the placebo. You will continue to receive 
it every 8 hours for four days following surgery. This will take no extra time for you.
During your admission you will be evaluated for your level of perceived pain, your sedation 
level, occurrence of narcotic and non-narcotic side effects such as nausea, vomiting, allergic 
reaction, and overall narcotic drug usage. These steps will take no extra time for you.
At the time of discharge you will be asked to fill out a brief pain perception assessment survey. 
This asks questions about how severe the pain may have been during the admission and 
whether the staff were responsive to your needs with respect to pain management. This should 
take less than one-half hour. 
RISKS AND DISCOMFORTS: 
You have been invited to be in this research study because you are scheduled to have a 
posterior spine fusion with instrumentation for severe scoliosis. That procedure is not 
experimental and is not part of this study, and the risks will be discussed with you separately.
There are risks involved in participating in the study, some of which may be very serious.
Study Drug Risks
Risks include allergic reaction, which may appear as a rash, hives, fever, swollen lymph nodes, 
swollen lips/tongue, unusual bruising, and/or severe fatigue. 
Other potential risks include: 

changes in blood pressure,

swelling in the extremities

joint pains.
There are risks of behavioral changes, emotional instability, hostility, confusion, and 
restlessness. 
The study drug may also cause 

blurred or abnormal vision,

temporary dizziness,

sleepiness and other symptoms and signs of decreased consciousness when given with
narcotic medications such as morphine. For these reasons it is advised not to operate
complex machinery while taking gabapentin.
The effects of gabapentin on pregnant patients, fetuses and in nursing mothers/infants have not 
been well studied and are potentially risky to pregnancy. 
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 4 of 7
Discomforts such as fatigue, diarrhea, dry mouth, constipation, nausea and vomiting have been 
reported. 
You may have some side effects we do not expect because we are still learning about 
gabapentin.
One risk to taking part in this study is that the study drug or the dose you receive may not be 
effective in helping to decrease your pain after scoliosis surgery. This means you may spend 
time in the study and experience side effects of taking a drug that may not provide you with any 
health-related benefits.
There are several drugs (prescription and non-prescription) that may cause problems when 
taken with the study drug.  The investigator will carefully review all of the drugs you are taking 
before giving you the study drug.  If any other health care provider prescribes any new drug(s) 
for you while you are in this study, please tell the investigator before you take the new drug.  
You could also have that provider talk to the investigator before prescribing the new drug.  Do 
not take any new over-the-counter drugs while you are in this study unless you first check with 
the investigator. The subject will be monitored for these side effects, and you are encouraged to 
report any behaviors or symptoms of concerned to healthcare providers.
BENEFITS:
You may or may not personally benefit from being in this study.  However, by serving as a 
subject, you may help us learn how to benefit patients in the future.
ALTERNATIVES: 
You may choose not to be in this study. If you choose not to be in this study you will not receive 
gabapentin during your admission for scoliosis surgery but you will continue to receive all of the 
other medications that we use to control pain in this situation including narcotic medications, 
anti-spasmodics (such as Valium), acetaminophen and ketorolac.
CONFIDENTIALITY 
We will take steps to keep your personal information confidential, but we cannot guarantee total 
privacy.  
We will create and collect health information about you as described in the Purpose and 
Procedures sections of this form.  Health information is private and is protected under federal 
law and Oregon law.  By agreeing to be in this study, you are giving permission (also called 
authorization) for us to use and disclose your health information as described in this form.
The investigators, study staff, and others at OHSU may use the information we collect and 
create about you in order to conduct and oversee this research study.
We may release this information to others outside of OHSU who are involved in conducting or 
overseeing research, including:

The Food and Drug Administration

The Office for Human Research Protections, a federal agency that oversees research
involving humans
We will not release information about you to others not listed above, unless required or 
permitted by law.  We will not use your name or your identity for publication or publicity 
purposes, unless we have your special permission.
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 5 of 7
When we send information outside of OHSU, it may no longer be protected under federal or 
Oregon law.  In this case, your information could be used and re-released without your 
permission.
We may continue to use and disclose your information as described above indefinitely.
Some of the information collected and created in this study may be placed in your OHSU 
medical record.  While the research is in progress, you may or may not have access to this 
information.  After the study is complete, you will be able to access any study information that 
was added to your OHSU medical record.  If you have questions about what study information 
you will be able to access, and when, ask the investigator.
COMMERCIAL DEVELOPMENT:
Information about you or obtained from you in this research may be used for commercial 
purposes, such as making a discovery that could be patented or licensed to a company.  There 
are no plans to pay you if this happens.  You will not have any property rights or ownership or 
financial interest in or arising from products or data that may result from your participation in this 
study.  Further, you will have no responsibility or liability for any use that may be made of your 
information.
COSTS:  
Some of the services or items in this study are part of the regular treatment for your condition.  
These would be performed or used even if you were not in this study.  The costs for these 
services or items will be billed to your insurance.  You will be responsible for any costs your 
insurance does not cover.  If you have any questions about these costs, or what out-of-pocket 
expenses you may be responsible for, contact your insurance company.  If you are uninsured, 
you will be responsible for these costs.  
You will not be billed for the costs of any services or procedures that are required by the study 
but are not considered part of your regular treatment.
LIABILITY: 
If you believe you have been injured or harmed while participating in this research and require 
immediate treatment
You have not waived your legal rights by signing this form. If you are harmed by the study drug 
or study procedures, you will be treated. Oregon Health & Science University does not offer to 
pay for the cost of the treatment. Any claim you make against Oregon Health & Science 
University may be limited by the Oregon Tort Claims Act (ORS 30.260 through 30.300). If you 
have questions on this subject, please call the OHSU Research Integrity Office at (503) 494-
7887.
PARTICIPATION:
If you have any questions regarding your rights as a research subject, you may contact the 
OHSU Research Integrity Office at (503) 494-7887.  
You do not have to join this or any research study.  You do not have to allow the use and 
disclosure of your health information in the study, but if you do not, you cannot be in the study.  
If you do join the study and later change your mind, you have the right to quit at any time.  This 
includes the right to withdraw your authorization to use and disclose your health information. If 
you choose not to join any or all parts of this study, or if you withdraw early from any or all parts 
of the study, there will be no penalty or loss of benefits to which you are otherwise entitled, 
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 6 of 7
including being able to receive health care services or insurance coverage for services.  Talk to 
the investigator if you want to withdraw from the study.
If you no longer want your health information to be used and disclosed as described in this form, 
you must send a written request or email stating that you are revoking your authorization to:
Your request will be effective as of the date we receive it.  However, health information collected 
before your request is received may continue to be used and disclosed to the extent that we 
have already acted based on your authorization. If you choose to withdraw there will be no 
ramifications with respect to your continued hospitalization or post-operative care.
You may be removed from the study if you develop serious side effects or if you do not follow 
study instructions.
If in the future you decide you no longer want to participate in this research, we will destroy all 
your information.  However, if your information is already being used in an ongoing research 
project and if its withdrawal jeopardizes the success of the entire project, we may ask to 
continue to use it until the project is completed.
We will give you any new information during the course of this research study that might change 
the way you feel about being in the study.
Your health care provider may be one of the investigators of this research study and, as an 
investigator, is interested in both your clinical welfare and in the conduct of this study.  Before 
entering this study or at any time during the research, you may ask for a second opinion about 
your care from another doctor who is in no way involved in this project.  You do not have to be 
in any research study offered by your physician.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. law. This web site will not include information that can identify you. At most, the web site 
will include a summary of the results. You can search this web site at any time.
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017


Page 7 of 7
SIGNATURES:
Your signature below indicates that you have read this entire form and that you agree to be in 
this study.  
We will give you a copy of this signed form. 
Subject/Parent/Guardian/Legally 
Authorized Representative Printed Name
Subject/Parent/Guardian/Legally 
Authorized Representative Signature
Date
Person Obtaining Consent Printed Name
Person Obtaining Consent Signature
Date
Complete if the participant is not fluent in English and an interpreter was used to obtain 
consent.  Participants who do not read or understand English must not sign this full consent 
form, but instead sign the short form translated into their native language.  This form should be 
signed by the investigator and interpreter only.
Print name of interpreter: ______________________________________
Signature of interpreter: ___________________________________  Date: _________
An oral translation of this document was administered to the subject in _____________ (state 
language) by an individual proficient in English and ____________ (state language). 
See the attached short form for documentation.
Approval Expires:  8/23/2018
IRB Approved:  8/29/2017