Clinical trial NCT03404518
Conditions: Outpatient Surgery Pain, Postoperative
Keywords: Thyroidectomy Parotidectomy Tympanoplasty Mastoidectomy Septoplasty Sinus Surgery Postoperative pain Outpatient surgery
Sponsor: Loma Linda University
Start date: 2018-02-21; Completion date: 2018-10-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.

Detailed description:
It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.

The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.

Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.

Arms: arm 1: This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.

If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. arm 2: This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.

If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.
Interventions: intervention 1: Norco intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control intervention 2: Ibuprofen as first line therapy every 6 hours as needed for pain control

Protocol documents:
Prot_SAP_001.pdf: 
 
 
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Title: Quantifying Narcotic Use in Outpatient Otolaryngology Procedures 
Brief: Patient Narcotic Requirements After Outpatient Otolaryngology Procedures 
Principal Investigator: Jared Inman, MD 
 
NCT#: 03404518 
Unique Protocol ID: 5170252 
Date of protocol creation: 12/16/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
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PROTOCOL OUTLINE AND GUIDELINES 
  
 
1. 
PROTOCOL INFORMATION  
Quantifying Narcotic Use in Outpatient ENT Procedures 
 
2. 
PRINCIPAL INVESTIGATOR’S INFORMATION 
Jared C. Inman, M.D., FACS, Associate Professor of Surgery 
Department of Otolaryngology-Head and Neck Surgery 
11234 Anderson Street, Suite 2584 
Loma Linda, California 92354 
 
3. 
STUDY PERSONNEL 
 
Khanh Nguyen, M.D. 
Loma Linda University Medical Center Department of Otolaryngology-Head and 
Neck surgery 
 
4. 
STUDY INFORMATION 
Study will be conducted in the Loma Linda University Medical Center affiliated clinic 
for Otolaryngology-Head and Neck Surgery.  
 
5. 
OBJECTIVE 
Opioid medication is routinely given for pain control after surgery. However, this has 
not been well studied with regards to the efficacy, and amount of medication that is 
required. Therefore the objective of this study is to quantify the efficacy of already 
standard practice. 
 
Approximately 200 patients will be enrolled in this study. The rationale and goal for 
this study is to provide a guideline for future patients undergoing similar procedures. 
 
6. 
INCLUSION / EXCLUSION CRITERIA 
Inclusion criteria: Adult patients between the ages of 18 and 89 years of age 
undergoing the following outpatient procedures at a Loma Linda University Health 
associated surgical facility: septoplasty, unilateral or bilateral functional endoscopic 
sinus surgery, rhinoplasty/vestibular stenosis repair, tympanomastoidectomy, 
tympanoplasty, total or partial thyroidectomy, parathyroidectomy, parotidectomy. 
 
Exclusion criteria: Patients under 18 years old; patients who are admitted after 
planned outpatient surgery; those allergic to Hydrocodone or NSAIDS; pregnancy; 
patients with chronic medical conditions including hepatic/renal disease, sickle cell 
anemia 
 
7. 
SUBJECT RECRUITMENT & SCREENING 
We plan to recruit about 200 patients for this study over the course of one year. We 
expect a high rate of participation as we are continuing with our usual practice for 
prescribing pain medication after surgery.  
 
Subjects will not be selected or excluded based on gender, ethnicity/race, native 
language or specific vulnerabilities. All patients who meet inclusion criteria will be 


 
 
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assessed and determined for candidacy for participation. Recruitment will take place 
on the morning of surgery and a screening questionnaire will be used for screening 
and as part of data collection should the patient agree to participate. Since we are 
continuing our standard treatment, no extraordinary risks are involved. The patient 
may opt out of the study at any time. 
 
8. 
INFORMED CONSENT PROCESS 
The primary investigator or one of the physician study personnel will obtain consent 
at the time of recruitment during the clinic visit or on morning of surgery. We will 
explain to the patient that participation in this study is entirely voluntary and that it 
will not change clinical management. If patient is unable to consent for himself or 
herself, we will exclude them from the study.  
 
9. 
STUDY DESIGN 
 
a. Background 
 
While it is routine practice to give analgesic medication after any surgical procedure 
to provide adequate pain control for patients, the abuse of prescription medications 
has recently become the fastest growing drug problem in the United States. More 
people died from prescription drug overdoses in 2014 than in any year on record with 
the majority of drug overdose deaths, more than 60%, involving an opioid. From 
2000 to 2014 nearly half a million people died from drug overdoses, and based on the 
2014 data, about 78 Americans die every day from an opioid overdose. The most 
common drugs involved in prescription opioid overdose deaths include Methadone, 
Oxycodone (such as OxyContin®), and Hydrocodone (such as Vicodin®), and it was 
also these three drugs that has the highest rate of opioid overdose death in 2014. 
 
Given the potential for narcotic abuse, as well as its impact on health care and societal 
cost, we wish to quantify baseline pain medication needs in patients who undergo 
outpatient ENT surgeries. Based on published data on postoperative pain and 
anecdotal experience, patients may not require as much narcotic medication as we 
have been prescribing. By providing patients with appropriate pain expectations and 
counseling, a clear regimen for pain control, and non-narcotic alternatives such as 
NSAID, we could likely decrease the amount of prescribed narcotic medication by 
25-50%. 
 
b. Literature review 
 
Other than septoplasty and tonsillectomy, very little has been studied to determine the 
appropriate amount and regimen for pain control after routine outpatient ENT 
procedures. One of the most comprehensive studies looking at postoperative pain in 
ENT procedures demonstrated that predictors of poor pain control after surgery 
includes preoperative pain, anatomic site, and higher pain catastrophizing scores. 
However, this study only looked at post-surgical pain up to 4 days after surgery and 
included a variety of ENT procedures including tonsillectomy, which is known to be 
an exceedingly painful procedure. Not only was the pain regimen utilized not 
common to what is used in the United States, this study did not separate inpatient 
versus outpatient procedures. 
 


 
 
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In another study looking specifically at patients who underwent parotidectomy, it was 
demonstrated that on a scale of 1-10 (10 being the worse imaginable pain), the mean 
pain score was only 3 on POD 1 with a range of 1 to 6. While this study did quantify 
the number of pain pills used on each day following surgery, it was unclear what the 
actual pain regimen was. What they did demonstrate very well was that post-surgical 
pain after parotidectomy is for the most part mild and at worst moderate. Similarly, in 
a study comparing open total and partial thyroidectomy with robotic total and partial 
thyroidectomy, pain after thyroid surgery was demonstrated to be only mild with the 
pain regimen that consisted of acetaminophen, tramadol and diclofenac. For those 
who had open surgery, the mean visual analog scale (VAS) score (from 1-10) on 
postsurgical day 1 was only 3.59 and 3.48 for total and partial thyroidectomy, 
respectively. While the study design suggested that all patients were admitted after 
surgery, this also was not clear. Interestingly, pain literature overall shows that 
treating pain under a VAS score 3 is not helpful and likely unnecessary and is 
definitely not recommended to require narcotic use. However, patients commonly 
take the prescription given by their surgeon with little to no education or 
understanding of pain thresholds or narcotic side effects. Anecdotally, many patients 
will state they did not use their narcotics as directed because they did not need them 
or that it did not help decrease the pain they were experiencing. Other patients 
seemingly take the medications as prescribed without question even though they were 
not experiencing pain. 
 
Overall, these studies suggest that certain ENT procedures may not be very painful 
for patients, thus begging the question of how much narcotic medication is actually 
needed for adequate pain control. An additional question that should be addressed is 
at what point does pain need to be treated and if so, does it require a narcotic 
medication? According to Gerbershagen and colleagues, a cut-off point of greater 
than or equal to 4 was determined to be the appropriate pain level to be considered 
moderate to severe where patients may benefit from analgesic therapy. A rating of 
less than 4 was considered to be tolerable pain. In a study of over 10,000 patients who 
underwent various types of surgeries, not only were patients asked their pain level, 
but they were also assessed whether this pain was tolerable. More than 50% of 
patients with a reported pain level of 4-6 reported pain as tolerable thus not requiring 
additional treatment. This study advised against adhering to a strict guideline of 
simply treating pain when greater than or equal to 4 and suggested clinicians to ask 
patients whether they desire to receive medication in order to prevent overtreatment 
and possibly unnecessary treatment. In a follow up study to determine at what point 
on the Numeric rating scale (NRS) should a patient be given a narcotic medication, 
only at an NRS of greater than or equal to 8 did more than 50% of patients desire to 
have an opioid medication for pain control. Interestingly, there were 314 patients in 
this study who had an ENT procedure and only 20 reported a desire to have opioid 
medication on POD 1 when patients were assessed. Ultimately, the conclusion from 
this study is that the NRS is not reliable to predict whether a patient requires narcotic 
medication, and again suggests that the patient’s preference for additional therapy 
should be assessed instead of following a rigid guideline for pain management. 
 
With this data and the implications of this topic in mind, the goal of this study is to 
quantify the amount of narcotic medication needed for adequate pain control for some 
of the most common outpatient ENT procedures. By providing a guideline and having 


 
 
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patients manage their own pain level, this could provide a truer assessment of patient 
needs based on their preference. 
 
c. Design: 
The study will be a prospective randomized study, and patients will be recruited 
before surgery. They will then be given an envelope assigning them to Group 1 or 
Group 2 pain regimen (see below). The patient will be prescribed both 
Hydrocodone/acetaminophen and Ibuprofen as described below, and instructed to 
follow the directions for their assigned group. They will be given other medications 
related to the procedure as needed.  
Following surgery, the patient will be discharged with the medications prescribed and 
asked to fill out a data sheet from post-operative day 1 (POD) to POD 7, recording 
their pain level three times per day as well as pain medication usage for each day. On 
follow up, the data sheet will be collected, marking the completion of patient 
participation. Patient data will then be analyzed for: the procedure that they 
underwent, pain level on each day after surgery, and amount of narcotic usage. The 
statistician will be blinded to which regimen the patients are on.  
 
Pain regimen: 
Group 1: 
1) First line: Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for 
pain control 
2) Second line: Ibuprofen 600mg every 6 hours as needed for pain control. Take 6o 
minutes after Hydrocodone/acetaminophen if pain is still not controlled. 
 
Group 2: 
1) First line: Ibuprofen 600mg every 6 hours as needed for pain control 
2) Second line: Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for 
pain. Take 60 minutes after Ibuprofen if pain still not controlled. 
 
 
10. 
DATA COLLECTION 
Consenting patients who meet the study criteria will be provided with the following 
handouts: (1) an instruction sheet explaining the study; (2) a consent form for 
participation (to be given back to the attending or resident physician); (3) the 
assigned study group with instructions, as described above; (4) a data sheet, where 
the patient will record the data after surgery.  
 
Beginning on the night after surgery, the patient will record the following: (1) pain 
level at morning (0800), midday (1300), and night (2000); (2) time when medication 
is taken, which medication is used, pain level when medication is taken. All of the 
data mentioned will be recorded daily until POD 7 or the first follow-up appointment 
(whichever comes first). At this time, the attending will collect the patient 
questionnaire and data sheet and store them in a secure location. If the patient 
forgets to bring the data sheet, the clinic will provide a self-addressed envelope for 
the patient to mail in the data.  
 


 
 
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11. 
LABELING & STORAGE OF DATA & SPECIMENS 
Subjects will be identified by medical record number only, and all study materials 
will be kept in a locked drawer or on a secure, password protected desktop computer 
at the Otolaryngology clinic at the Faculty Medical Office (FMO) or Orange Tree 
Lane Otolaryngology(OTL) clinic. Every effort will be made to protect patients’ 
private information and the only information gleaned from the electronic medical 
record will be demographic information for the purposes of the study. 
 
 Aside from the medical record number, which will be kept secure, no identifying 
information will be used. All forms related to Privacy of Medical and Research 
Records information / medical records, Medical Release forms, HIPAA 
compliance/authorization forms will be signed by the patient and copies given to them 
if requested as patients are enrolled in the study. 
 
12. 
DATA ANALYSIS 
Data will be analyzed by investigator at the conclusion of the study with descriptive 
statistics reported as means with 95% CIs. For comparison between the treatment 
groups, Student’s t test and Fisher’s exact test will be used as appropriate, with 
statistical significance defined as P < .05.  
 
For comparison of multiple surgical groups, single-factor analysis of variance will be 
used and the following independent variables evaluated as factors for reported pain 
scores and opioid usage: age, sex, prior opioid use, liver or kidney disease, chronic 
pain, tobacco, alcohol, marijuana, benzodiazepine, surgery type, surgery length, and 
revision surgery. Univariate linear regression and multivariate linear regression will 
be used to determine factors most predictive of higher reported pain scores and/or 
opioid consumption.  
 
13. 
RISK AND INJURY 
Patients in this study will receive standard outpatient pain regimens, which are 
already in practice, with no changes. There is no additional risk, as we are using the 
same medications that we currently use and are within the standard of care. All 
patients receiving pain medications are given printed prescription warnings from the 
pharmacy. The only specific risk could be the unintended disclosure of HPI if the 
research protocols are not followed; however, standard research protection steps will 
be taken.  
 
14. 
BENEFIT(S) 
Patient will receive no benefit in addition to that received from the current standard 
of care.  
 
15. 
COMPENSATION 
No compensation will be offered in exchange for participation in our study. 
 
16. 
CONFIDENTIALITY 
No patient identifiers will be used in this study. Medical record will be used to gather 
demographic information only. All study information will be kept secure in either a 
locked drawer or password protected hard-drive. No patient information will be 
shared or distributed at any time.  


 
 
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17. 
REFERENCES: 
 
1. Results from the 2009 National Survey on Drug Use and Health (NSDUH): 
National Findings, SAMHSA (2010). 
 
2. Centers for Disease Control and Prevention. Increases in Drug and Opioid 
Overdose Deaths — United States, 2000–2014. MMWR 2015; 64;1-5. 
 
3. Ossiander EM. Using textual cause-of- death data to study drug poisoning. 
Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 
Feb. 1112. 
 
4. Sommer, M., et al, Prevalence and Predictors of Postoperative Pain After Ear, 
Nose, and Throat Surgery, Arch Otolaryngology Head and Neck Surgery, Vol 135, 
2009 
 
5. Foghsgaard, S., et al, Early post-operative morbidity after superficial 
parotidectomy: a prospective study concerning pain and resumption of normal 
activity, Clinical Otolaryngology, Vol 32, 2007 
 
6. Song, C., et al., Postoperative pain after robotic thyroidectomy by a gasless 
unilateral axillo-breast or axillary approach, Surgical Laparoscopy Endoscopic 
Percutaneous Technique, Vol 25, 2015 
 
7. Gerbershagen H., et al, Determination of moderate-to- severe postoperative pain on 
the numeric rating scale: a cut-off point analysis applying four different methods, 
British Journal of Anaesthesia, 107 (4):619-26, 2011 
 
8. Van Djik, J., et al, Postoperative pain assessment based on numeric ratings is not 
the same for patients and professionals: A cross-sectional study, International Journal 
of Nursing Studies, 49: 65–71, 2012 
 
9. Van Djik, J., et al, The relation between patients’ NRS pain scores and their desire 
for additional opioids after surgery, Pain Practice, Vol 15, Iss 7, 604-609, 2015