Pain After Tonsillectomy Study
Phase: NA
Conditions: Pain, Postoperative
Sponsor: University of Calgary

 
Ethics ID: REB17-1794 
Study Title: Pain After Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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TITLE: Pain After Tonsillectomy (PAT) Study 
 
SPONSOR: Alberta Children’s Hospital Foundation  
 
PRIMARY INVESTIGATOR: 
Melanie Noel, PhD, R.Psych 
 
CO-INVESTIGATORS: 
 
Nivez Rasic, MD FRCPC, 
 
  
 
 
Susan Graham, PhD, 
 
  
 
 
Jill M Chorney, PhD, 
 
  
 
 
Jill Vinall, PhD, 
 
  
 
 
James Brookes, MD, 
Warren Yunker, MD, PhD, FRCSC 
Derek Drummond, MD, 
Monica Hoy, MD, 
Maria Pavlova, MSc 
 
BACKGROUND: 
 
Pain is a common experience in childhood. Healthy children who are compliant with medical 
care undergo up to 20 painful procedures by the age of 5.1 Moreover, millions of children 
undergo surgery (e.g., tonsillectomies) each year, which is commonly linked to pain and 
distress.2 Pain from, and fear of, medical experiences are neither short lasting or benign and can 
influence children long after the painful stimulus is removed.3 Children’s memories of needle-
related, experimental, post-surgical, and procedural pain are a powerful predictor of future pain 
experiences, and are sometimes more influential to future pain than the initial experience of pain 
itself.4-6 Memory is susceptible to distortion. Negative biases in pain memories (i.e., recalling 
higher levels of pain as compared to initial pain report) are associated with higher subsequent 
pain, distress, and worse medical compliance.4,7 Empirical and theoretical work3,8 has implicated 
a number of factors in the development of negatively biased pain memories in children. Child 
sleep and language abilities have been shown to influence memory development following 
stressful and painful events.9-11 Children who are more anxious and who experience greater pain 
are more likely to develop negatively biased pain memories,12 which then leads to greater fear 
and pain at subsequent pain experiences.5 Parents and adolescents who think in more 
catastrophic ways about child pain prior to surgery tend to develop more negatively biased pain 
memories months later.13 In fact, parents’ catastrophic thinking about child pain was found to be 
the single most important predictor of children’s memory biases13 and subsequent pain 
trajectories.14 It has been suggested that parental and child anxiety lead to memory biases 

Ethics ID: REB17-1794 
Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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because of the ways in which parents and children talk about pain following painful events (e.g., 
by emphasizing threatening aspects of the experience).8 
We recently published a conceptual developmental framework in the journal PAIN8 outlining 
the cognitive and social factors that are thought to influence children’s pain memory 
development (Figure 1). Of particular importance is early childhood (ages 4-7 years) when 
children are most susceptible to memory biases due to suggestibility effects. It is also during this 
time that parents are most influential in shaping children’s cognitions, emotions, and behaviors.8 
Our model posits that the socio-linguistic context (e.g. parent-child narratives about pain) in 
which pain memories develop is most important in early childhood and sets the stage for future 
pain experiences.  
There have only been a few studies examining memory reframing interventions in the 
context of children’s recall of (needle) pain. In our recent systematic review, existing trials of 
memory reframing interventions were found to be efficacious in reducing negative memory 
biases.15 Indeed, parent-child language-based interactions about past negative events play a 
powerful role in how autobiographical memories of those events are subsequently retrieved and 
reframed.16 Parent-child narrative style also influences children’s coping and psychological 
functioning.16 Young children whose parents are topic-extending and elaborative (e.g., who ask 
open-ended questions to pull for richer, more detailed accounts of the past) and who use 
emotional language, have children who are more accurate and detailed in recalling their pasts, 
which is adaptive.17  
Figure 1. Cognitive and social developmental factors underlying the formation and expression 
of pain memories in childhood. 

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Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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Recent data from our lab provides compelling evidence that parents who reminisce with their 
children about surgery using a particular style (e.g., more elaborative, less topic-switching) and 
content (e.g., less content about pain, fear, medical procedures; more explanations) have children 
who later remember post-surgical pain in a more accurate and positively biased way. Parental 
reminiscing style and content have been effectively targeted in interventions to improve 
children’s memory development. However, memories of post-surgical pain, that can be 
negatively biased and lead to persistent pain problems,4 have not been targeted, despite a relative 
dearth of, and need for, interventions for this pediatric population.18,19 Moreover, existing 
memory reframing interventions did not employ parents, who play a critical role in children’s 
pain memory formation and are underutilized intervention agents.16,20 Indeed, parents are 
potentially the most powerful and accessible agents of change, and our recent data provides 
strong evidence that the language parents use when reminiscing with children following 
tonsillectomies influences children’s pain memory biases. Interventions requiring an 
interventionist and separate visits have limited utility in routine clinical practice. Engaging 
parents would greatly increase the availability of such interventions. 
The objective of the proposed research study is to conduct a pilot study to examine the 
preliminary efficacy, feasibility, and acceptability of a brief parent-led memory reframing 
intervention following pediatric surgery to foster more adaptive (i.e., less negatively biased) 
pain memories. The intervention will draw from our recent data and extant memory reframing 
and narrative-based intervention techniques to promote more accurate/positive pain memories by 
teaching parents more adaptive styles of reminiscing with their children about a past surgery. We 
will accomplish our aims by extending our existing program of research on post-surgical pain 
memory development of children (aged 4-7 years) and randomly assigning parents to receive a 
memory reframing intervention or attention control following surgery and subsequently 
assessing children’s memories for pain. This study will be the first to develop and pilot test a 
brief, parent-led intervention aimed at changing the way children recall their pain after surgery, 
thereby extending memory-reframing techniques to the post-surgical pain context. Given the 
integral role of pain memories in shaping future pain experiences and the need for interventions 
in the pediatric surgery context,18,19 this study has great potential to contribute an accessible and 
feasible post-surgical pediatric pain management intervention and foster more adaptive pain 
trajectories and medical experiences in childhood. 
 
STUDY AIMS 
 
Primary Aim 
1) To examine the preliminary efficacy, feasibility, and acceptability of a parent-led 
memory reframing intervention on children’s post-surgical pain memories.  
Hypothesis 1: Children in the intervention group will go on to recall post-surgical pain in 
a more accurate or positively biased way as compared to the control group who will 
remember pain in a more negatively biased way. The intervention will be judged by 
parents to be feasible and acceptable.  

Ethics ID: REB17-1794 
Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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Secondary Aim 
2) To examine the influence of baseline individual child and parent characteristics on 
children’s pain memories.  
Hypothesis 2: Children who are more anxious, less self-efficacious, have worse sleep 
quality, and whose parents are more anxious and catastrophize more about child pain 
prior to surgery will subsequently remember pain in a more negatively biased way.  
 
METHODS 
 
Sample 
One hundred children (50 intervention, 50 control) between the ages of 4-7 years and one 
of their parents will be recruited from the Ear Nose and Throat Clinic at Alberta Children’s 
Hospital, where the PI’s research laboratory is housed. A child will be eligible to participate in 
the proposed study if he/she 1.) is between 4 and 7 years old at the time of recruitment; 2.) is 
scheduled for an elective outpatient tonsillectomy (with or without adenoidectomy); 3.) is able to 
understand and speak English 4.) has at least one of his/her parents/caregivers consent to 
participating in the study and this caregiver is able to speak and read English.  
Exclusion criteria include: 1) receiving pre-medication with anxiolytics (Midazolam; 
administered to < 5% of youth), as it might interfere with child’s preoperative anxiety21 and 
memory formation;22 2) serious medical co-morbidities (American Society of Anesthesiologists 
[ASA] ≥ III physical status) that would interfere with standardized protocols of analgesic 
administration and surgical technique; 3) developmental disabilities or speech/language delays, 
as it may make it difficult for the participants to complete all necessary study tasks (e.g., assent, 
narrative task, memory interview).  
 
Procedure 
Patients will be identified through surgery schedule lists. At entry into the clinic, a 
member of the Ear, Nose and Throat Clinic will provide potentially eligible patients with 
information about the study. Parents provide permission to be contacted by the research team. 
Several weeks before surgery, a member of the research team will conduct a recruitment phone 
call with all eligible patients' parents to discuss the study. Following the recruitment phone call, 
online consent forms will be emailed to interested participants. Parents will provide consent for 
the child’s participation; children, who are 7 years old or over or turn 7 during the course of 
participation in the study, will provide assent. One week before surgery, parents will complete 
measures of parent catastrophizing about child pain, child language, and child sleep. For 
descriptive purposes, parents will report on socio-demographics (parent education, child age, 
household income), preparation that they/their child received about the surgery and what this 
entailed (e.g., coping skills, pain management), and family history of tonsillectomies and 
surgeries. On the day of surgery, measures of parental state anxiety will be obtained as well as 
children’s levels of pain and pain-related fear. A trained observer will objectively assess 

Ethics ID: REB17-1794 
Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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preoperative child anxiety at the time of anesthesia induction using a well-validated behavioral 
scale (described below).  
As per standard clinical care (the following has been indicated by our Anesthesiologist 
colleague, Dr. Nivez Rasic): In Day Surgery, all patients will receive Tylenol 15 mg/kg orally 
pre-operatively, unless there is a specific contraindication. One parent may be present at 
anesthesia induction with their child. The child will receive an inhalational induction with 
sevoflurane, oxygen, and nitrous oxide. An intravenous will then be inserted, and the child will 
be maintained on either volatile anesthetic or total intravenous anesthetic (TIVA) for the 
procedure. The child will then be extubated deep or awake at the end of the procedure and 
transferred to the Post-Anesthesia Care Unit (PACU). During the procedure, all patients will 
receive dexamethasone 0.2 mg/kg IV, ondansetron 0.1 mg/kg IV, and morphine for analgesia.  
Again, as per standard clinical care: All of the ENT surgeons will use cautery to the tonsillar bed 
as their surgical technique for tonsillectomy with or without adenoidectomy. The patients will be 
recovered in the PACU. A decision of whether or not to bring a parent or caregiver into the 
PACU will be made at the discretion of the PACU nurse and the anesthesiologist. Information 
regarding the surgical technique used and analgesic and anesthetic agents administered on the 
day of surgery will be collected via medical chart review (using Clinibase and Sunrise Clinical 
Manager).  
A researcher will obtain ratings of child pain intensity shortly following surgery and 
again prior to discharge home. Parents will be given and instructed on how to administer the pain 
scales so that child-reports of pain can be captured at home. These scales and instructions will 
also be provided to parents via emailed survey links (REDCap). Consistent with timelines used 
in previous studies,23 proxy and self-reports of child average and worst pain intensity and pain-
related fear will be assessed on days 1, 2, 3, 7 and 14 post-surgery. Proxy-reports of child sleep 
will be assessed on day 14 post-surgery. Parents will also report on the use of analgesics at 
home. At 2-weeks post-surgery, parents and children will come to the PI’s research lab within 
the Vi Riddell Pain Centre at Alberta Children’s Hospital during which time they will be 
randomized into an intervention or control group. Randomization will be conducted by an 
external statistician using a computer random number generator. Allocation concealment will be 
achieved using sequentially numbered, opaque, and sealed envelopes. Group allocation will be 
revealed by a researcher at the outset of the lab visit.  
During the lab visit, parents in both groups will talk to a researcher for approximately 20 
minutes while another researcher plays with the child (e.g., watching a video, coloring, playing 
toys) in a separate room.  
Control Group. Similar to previous narrative and memory interventions, parents in the 
control group will receive instructions from a researcher on how to engage in child-directed 
play.24 Importantly, they will not talk about pain or the past surgery experience. After this 20-
minute period, parents in the control group will be instructed to reminisce with their children 
about the in-hospital and post-surgery periods as they normally would. 
Intervention Group. Parents in the intervention group will spend the same about of time 
(20 minutes) with a researcher and receive instructions about adaptive ways of reminiscing about 

Ethics ID: REB17-1794 
Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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the in-hospital and post-surgery periods. The intervention will draw from existing narrative-
based interventions that have taught parents to reminisce with their children about past negative 
events in more elaborative and emotion-rich ways (e.g., using more open-ended questions, to 
follow up on children’s answers by providing new details about the event, to talk more about 
emotions, and to praise children’s answers). We will also include elements of past pain memory 
reframing interventions and findings from our recent data. Specifically, parents will be taught to 
reminisce with their children about the in-hospital and post-surgery periods by providing more 
explanations for events, using less utterances about pain, fear, and medical procedures, 
emphasizing positive aspects of the child’s surgery memory (e.g., when children used coping 
methods such as deep breathing, when they got a treat),25 and enhancing children’s self-efficacy 
regarding their ability to cope with pain.26 Similar to previous interventions, to boost mastery of 
the material, the researcher will use short videos of prototypical parent-child reminiscing about 
the in-hospital and post-surgery periods to illustrate adaptive and maladaptive reminiscing style 
and content. Researchers will also provide suggestions for specific questions and remarks to 
make while reminiscing. Parents and researchers will engage in brief role-plays to solidify the 
techniques, which will be followed by researcher feedback. After this training period, parents in 
the intervention group will be instructed to reminisce with their children about the in-hospital 
and post-surgery periods using the intervention strategies.  
After parents have finished reminiscing about the in-hospital and post-surgery periods 
with their child, parents in both groups will be asked to complete a short questionnaire 
containing similar measures as completed at baseline. 
Three to four weeks after surgery, children in both groups will complete a telephone pain 
memory interview to assess children’s recall of the in-hospital and post-surgery periods.13,27 
Then, parents in the intervention group will complete a brief semi-structured telephone interview 
to assess feasibility and acceptability of the intervention.19,28 
 
Incentives 
 
As a token of appreciation for their commitment to the study, each family (a parent and a 
child) will receive $20 gift card (e.g., to Amazon.ca, ToysRUs, etc.) at the end of the lab visit 
and another $20 gift card after the completion of the memory interview. Given the longitudinal 
nature of the study, we consider this to be a modest incentive that will not coerce participants 
into participation. Moreover, it is consistent with honoraria provided in our previous studies of 
similar nature. Families will also be reimbursed for any parking costs during their lab visit. 
 
Measures 
Child state anxiety. Proxy ratings of children’s state anxiety will be assessed by parents using a 
numeric 0-10 scale (NRS). Parents and research assistants will use the NRS to provide proxy 
ratings of the child’s state anxiety in the preoperative holding area and operating room.29 
Child pain-related fear. Children’s pain-related fear will be assessed using the Children’s Fear 
Scale (CFS).30 This scale depicts five faces of varying degrees of fear from ‘not at all scared’ to 

Ethics ID: REB17-1794 
Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
Date: December 4, 2017 
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‘most scared possible’. It shows evidence of good concurrent and discriminant validity and test-
retest reliability.30  
Child preoperative anxiety. The 27-item Modified Yale Preoperative Anxiety Scale (mYPAS)31  
will be used by two trained observers to assess preoperative anxiety. The mYPAS assesses five 
domains of behaviour: activity, emotional expressivity, state of arousal, vocalization, and use of 
parents. Higher scores indicate greater preoperative anxiety. The scale has been shown to be 
reliable and demonstrated high convergent validity when validated against other behavioural 
measures of pediatric anxiety.32 
Child post-operative pain. Pain intensity will be assessed using a well-validated single-item 
faces pain scale (Faces Pain Scale-Revised; FPSR),33 by parents (proxy reports of child pain) and 
children themselves. A parent-report behavioural checklist (Parent’s Postoperative Pain Measure; 
PPPM)34 will also be used. The FPSR is the most psychometrically sound measure of pain 
intensity for children in this age range.35 The PPPM is a 15-item measure intended for use with 
parents of children aged 2-12 to reliably evaluate child pain after surgical procedures. It is 
intended for use at home and is the most validated observational measure of postoperative pain.36 
Child self-efficacy. Parents and children will rate their pain-related self-efficacy regarding post-
surgical pain. Children will use a 100-mm visual analogue scale (VAS) to assess “how well 
(they) think (they) will do after surgery”.26 Parents will rate their self-efficacy about their ability 
to control their child’s post-surgical pain on a 0-10 Numerical Rating Scale.  
Child sleep quality. The 26-item Sleep Disturbance Scale for Children (SDSC) will be used to 
assess parental reports of child sleep quality.37 The SDSC yields six subscales: sleep initiation 
and maintenance, sleep-related breathing disorders (SRBD), sleep arousal, sleep-wake transition 
disorders, excessive daytime sleepiness, and sleep hyperhydrosis. The SDSC has been validated 
for use with children aged 3 to 18 years,37,38 and shows strong evidence of reliability and validity 
against polysomnography.39  
Child language and communication skills. The Children's Communications Checklist-2 (CCC-
2)40 is a psychometrically sound 70-item measure designed to assess communication skills and to 
identify clinically significant language and speech impairment in youth aged 4-16 years. The 
CCC-2 assesses articulation, phonology, language structure, and vocabulary, as well as 
pragmatic aspects of children's communication skills. Items assess areas of strengths and 
weaknesses and are rated on a 4-point Likert frequency scale. 
Parent state and trait anxiety. Parents will use the 40-item State-Trait Anxiety Inventory (STAI) 
to assess their own state and trait anxiety.41 Items are rated on a 4-point Likert Frequency Scale. 
The STAI has been used to assess parents’ anxiety during children’s tonsillectomies42 and has 
excellent psychometric properties.43 Parents will also use an NRS to report how anxious they feel 
about the child’s upcoming tonsillectomy 1 week before the surgery and before anesthesia is 
given to their child. If anxiety ratings are 1 or greater at the first point of assessment, a follow-up 
question will be asked to determine the specific content of their anxiety (e.g., anesthesia, pain 
control, surgery, side effects, etc.).  
Parent catastrophic thinking about child pain. The Pain Catastrophizing Scale-Parent Version 
(PCS-P) is a 13-item self-report measure that assesses catastrophic thoughts and feelings that 
parents may have when their child experiences pain.44 Items on the PCS-P are rated on a 5-point 
Likert scale. The PCS-P is both valid and reliable among parents of youth with and without pain 
problems.44 

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Study Title: Pain after Tonsillectomy Study 
PI: Dr. Melanie Noel 
Version: 2 
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Feasibility. Similar to previous research,28 feasibility will be assessed using study 
recruitment/enrollment statistics, completion of the study elements; and researchers’ and parents’ 
ratings of parents’ motivation to learn, understanding of the intervention, and parent-child and 
parent-researcher rapport rated on 11-point Likert scales.  
Acceptability and satisfaction. Acceptability will be assessed at study completion (i.e., after 
memory interviews). The parent-report 9-item Treatment Evaluation Inventory-Short Form (TEI-
SF) will be used to assess parental acceptability and satisfaction with the intervention; however, 
items will be slightly modified to pertain to the memory reframing intervention. Semi-structured 
telephone interviews will be conducted to assess treatment satisfaction and elicit feedback.28  
Parent-child narratives. Narratives will be video-recorded, transcribed, broken down into 
utterances, and coded by two independent coders using established coding schemes derived from 
the child development literature on children’s narratives and memories.45 Coders have been 
trained and will be blinded to treatment condition. The following aspects of narratives will be 
coded: Reminiscing style/level of elaboration (elaboration vs. repetition) and content (e.g., 
references to pain, anxiety/fear, medical procedures, emotions, explanations). Proportions of 
narrative utterance type over the entire number of utterances used will be calculated. Based on 
previous research,8,17 the primary narrative codes for the analyses will be parent reminiscing 
style (elaboration), and content related to pain, anxiety, medical procedures, and explanations. 
Inter-rater reliability will be calculated using intra-class correlation coefficients.  
Memory. Three to four weeks following surgery, children will be asked to complete a pain 
memory interview via telephone that is based on a previously published protocol used with 
children aged 5-10 years following venipuncture.27 Children will be asked to recall the in-
hospital and post-surgery periods (i.e., while at home) time periods and complete the same pain 
intensity and pain-related fear scales based on their memories of those time periods. Biases in 
memory will be defined as the deviation in recalled and initial/experienced pain reports. Similar 
to our previous research, statistical models predicting pain memories will control for initial pain 
ratings that correspond to each memory question.4,9,10 Negatively biased pain memories will be 
defined as children who remember more pain and fear as compared to their initial pain reports. 
Positively biased pain memories will be defined as recalled pain that is less than initial pain 
reports. Accurate memories reflect no difference between recalled and experienced levels of 
pain. 
Medical records review. Through the medical records review, we will gather information about 
the surgery technique, parental presence at induction, anesthetic technique (maintenance with 
volatile or TIVA), intraoperative opioid administration, awake or deep extubation, duration of 
PACU stay, pain scores using FPSR, analgesic administration, parental presence in PACU, 
analgesic administration in Day Surgery (and overnight stay if that applies), etc.   
Analgesic consumption after discharge. Analgesic administration (or absence thereof) will be 
recorded after discharge on days 1, 2, 3, 7, and 14 at home. The questions will include medicine 
type (including any specific remedies to reduce pain due to swallowing), dose, and number of 
times medicine was administered.  

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PI: Dr. Melanie Noel 
Version: 2 
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Socio-demographic forms. A brief socio-demographic form will be administered to account for 
such variables as ethnic background, level of education, household income, and family 
composition.  
Medical history questionnaire. A brief questionnaire will be administered to assess variables 
such as family surgical and medical history and surgery preparation and knowledge.  
 
Statistical Analyses 
A sample size of 52 children is required to detect medium effect sizes and exceeds the 
published recommendations for pilot interventions.46 We will inflate the sample size to N=100 
(50 per group) to account for attrition rates. 
Group differences in memory will be analyzed using analysis of covariance, while 
controlling for child age, sex, language ability, and initial pain ratings. Similar analyses will 
examine group differences in pain narratives to provide evidence of treatment fidelity. Feasibility 
and acceptability will be summarized using descriptive statistics. Hierarchical regression models 
will be used to examine the predictive value of child and parent characteristics on pain 
memories. Prior to consideration for inclusion in the models, variables will be subjected to 
multicollinearity diagnostics via assessment of variance inflation factors. Remaining candidate 
variables will be included in the models. Similar to previous research, semi-structured interviews 
will be conducted with parents to assess acceptability and satisfaction. Interviews will be 
analyzed using semantic thematic analysis conducted using NVivo software.19 
 
TIMEFRAME 
 
A 9-month timeframe is proposed for the completion of the present pilot study project: 7 
months will be needed for continuous recruitment of participants. We aim to recruit 15 families 
per month. The final two months will be used to complete the last wave of memory interviews 
and data entry, run statistical analyses and prepare manuscripts for publication.  
 
 
 

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