- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05482919
The Adolescent Surgery Experience: A Mixed Methods Analysis
March 28, 2024 updated by: Children's Hospital of Philadelphia
New chronic pain and opioid use are reported as prevalent among adolescents undergoing major surgery; many unanswered questions remain regarding recovery and the anticipated pain trajectory across procedures and the interaction between pain treatment, acute inflammation and new chronic pain.
Broadly, the proposed study will characterize the adolescent's postoperative recovery experience, and establish the anticipated pain trajectory across a range of procedures.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The proposed study will characterize the adolescent's postoperative pain and recovery experience.
Using a mixed methods design, Investigators will follow a diverse cohort of up to 500 adolescents undergoing surgery at the Children's Hospital of Philadelphia (CHOP) over six months to systematically characterize their recovery trajectory.
The primary objective is to characterize development of new chronic pain in the context of longitudinal pain trajectories among adolescents in the first 6 months after surgery and to quantify implications of post-surgical pain and pain treatment.
The secondary objectives are to determine factors associated with prolonged opioid use after surgery compared to peers (measured in days to discontinuation) and to characterize factors associated with delayed recovery from surgery compared to peers.
A baseline survey, including an anxiety and depression screen using the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) surveys will be collected after consent and prior to surgery; subsequent post-operative surveys will be collected at one & two weeks, one month, then monthly up to 6 months with total of 8 surveys.
The PHQ-9 and GAD-7 will also be administered on month 1, month 3, and month 5.
A subgroup of patients will be invited to complete a qualitative interview one month and three months after surgery (+/- 14 days).
Adolescents may participate in the 3-month interview if they did not participate in the 1-month interview.
The team will select adolescents who report higher pain scores compared to peers undergoing similar procedures on the Weeks 1, 2 and 3 month surveys and a sample of adolescents who are recovering as anticipated.
Interviews will take place via telephone or CHOP approved videoconferencing platform with transcription and transcripts, entered in REDCap, that only contain the patient's study identification (ID) as a personal identifier.
It is anticipated that some adolescents will decline participation in the one-month survey; they will not be approached to participate in the three-month survey unless they indicate willingness to receive an invitation upon submitting the Month 3 survey.
It is also anticipated that individuals may decline to participate in the three-month survey and Investigators will plan to extend additional invitations to complete approximately 25 interviews at each interval.
Study Type
Observational
Enrollment (Actual)
501
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paula Hu, RN MSPH
- Phone Number: 267225214
- Email: hup@chop.edu
Study Contact Backup
- Name: Kellie Patterson, RN BSN
- Phone Number: 4843623664
- Email: pattersok3@chop.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study will enroll up to 500 adolescents age 11-21 years undergoing surgery at all CHOP surgical sites
Description
Inclusion Criteria:
- Males or females age 11 to 21 years
- Scheduled for non-cardiac surgery at one of five CHOP surgical centers
- American Society of Anesthesiologists Physical Status (ASA) ≤ 3
- Girls 11 years of age and older must have a negative urine/serum pregnancy test
- Parental/guardian permission (informed consent) if participant <18 years old and if appropriate, child assent
Exclusion Criteria:
- Subjects with limited English proficiency.
- History of chronic pain
- History of prior opioid use >5 consecutive days for acute pain or >10 consecutive days for major surgery in their life time
- Pregnant or lactating females
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of new chronic pain
Time Frame: 7 months
|
Incidence of new chronic pain, using the International Association for the Study of Pain (IASP) definition at 3 months after surgery, among a diverse cohort of adolescents undergoing major surgery.
Prior reports in the adolescent surgery literature have suggested that 20% of patients develop chronic pain, defined as surgical site pain that persists more than three months after surgery.
Here, Investigators have hypothesized that a lower chronic pain incidence of 11% exists among adolescents at CHOP after undergoing major surgery.
Therefore using a two-sided Wald test to detect a significant difference from historic estimates, Investigators will enroll a minimum of 115 patients undergoing major surgery (a=0.05;
b=0.1; n=95, assuming conservative 20% loss of follow-up).
The remainder of the up to 500 subjects will represent a variety of procedures associated with mild, moderate and severe postoperative pain to characterize recovery trajectories.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged opioid use compared to peers undergoing similar surgeries
Time Frame: 7 months
|
Factors associated with prolonged opioid use after surgery, measured in time to opioid discontinuation after surgery, compared to peers undergoing similar surgeries
|
7 months
|
Delayed recovery compared to peers
Time Frame: 7 months
|
Factors, including elevated average and maximum NRS scores, GAD-7 and PHQ-9 scores, and Screening to Brief Intervention (S2BI) scores, associated with delayed recovery from surgery compared to peers undergoing similar surgeries.
For the NRS scale, which ranges from 0-10, a response of '0' corresponds to "no pain" while a response of '10' corresponds to extreme severe pain (e.g., "worst pain imaginable").
For the GAD-7 scale, a score of 5-9 corresponds to mild anxiety, 10-14 to moderate anxiety and 15+ to severe anxiety.
For the PHQ-9 scale, 4 or more items selected in the shaded section corresponds to a possible depressive disorder with 5 or more corresponding to a possible major depressive disorder.
For the S2BI scale, a never response corresponds to no reported substance use, once or twice corresponds to lower risk substance use and more than monthly corresponds to higher risk substance use.
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tori N Sutherland, MD MPH, CHOP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Page MG, Stinson J, Campbell F, Isaac L, Katz J. Identification of pain-related psychological risk factors for the development and maintenance of pediatric chronic postsurgical pain. J Pain Res. 2013;6:167-80. doi: 10.2147/JPR.S40846. Epub 2013 Mar 5.
- Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.
- Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.
- Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. doi: 10.1016/j.dr.2007.08.002.
- Rabbitts JA, Palermo TM, Zhou C, Mangione-Smith R. Pain and Health-Related Quality of Life After Pediatric Inpatient Surgery. J Pain. 2015 Dec;16(12):1334-1341. doi: 10.1016/j.jpain.2015.09.005. Epub 2015 Sep 28.
- Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.
- Rabbitts JA, Palermo TM, Zhou C, Meyyappan A, Chen L. Psychosocial Predictors of Acute and Chronic Pain in Adolescents Undergoing Major Musculoskeletal Surgery. J Pain. 2020 Nov-Dec;21(11-12):1236-1246. doi: 10.1016/j.jpain.2020.02.004. Epub 2020 Jun 15.
- Ward A, Jani T, De Souza E, Scheinker D, Bambos N, Anderson TA. Prediction of Prolonged Opioid Use After Surgery in Adolescents: Insights From Machine Learning. Anesth Analg. 2021 Aug 1;133(2):304-313. doi: 10.1213/ANE.0000000000005527.
- Harbaugh CM, Lee JS, Chua KP, Kenney B, Iwashyna TJ, Englesbe MJ, Brummett CM, Bohnert AS, Waljee JF. Association Between Long-term Opioid Use in Family Members and Persistent Opioid Use After Surgery Among Adolescents and Young Adults. JAMA Surg. 2019 Apr 1;154(4):e185838. doi: 10.1001/jamasurg.2018.5838. Epub 2019 Apr 17.
- Chua KP, Brummett CM, Conti RM, Bohnert A. Association of Opioid Prescribing Patterns With Prescription Opioid Overdose in Adolescents and Young Adults. JAMA Pediatr. 2020 Feb 1;174(2):141-148. doi: 10.1001/jamapediatrics.2019.4878.
- Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29.
- Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.
- Rabbitts JA, Aaron RV, Fisher E, Lang EA, Bridgwater C, Tai GG, Palermo TM. Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers. J Pain. 2017 Jul;18(7):778-786. doi: 10.1016/j.jpain.2017.02.423. Epub 2017 Feb 21.
- Sieberg CB, Simons LE, Edelstein MR, DeAngelis MR, Pielech M, Sethna N, Hresko MT. Pain prevalence and trajectories following pediatric spinal fusion surgery. J Pain. 2013 Dec;14(12):1694-702. doi: 10.1016/j.jpain.2013.09.005.
- Kharasch ED, Clark JD, Adams JM. Opioids and Public Health: The Prescription Opioid Ecosystem and Need for Improved Management. Anesthesiology. 2022 Jan 1;136(1):10-30. doi: 10.1097/ALN.0000000000004065.
- Kelley-Quon LI, Kirkpatrick MG, Ricca RL, Baird R, Harbaugh CM, Brady A, Garrett P, Wills H, Argo J, Diefenbach KA, Henry MCW, Sola JE, Mahdi EM, Goldin AB, St Peter SD, Downard CD, Azarow KS, Shields T, Kim E. Guidelines for Opioid Prescribing in Children and Adolescents After Surgery: An Expert Panel Opinion. JAMA Surg. 2021 Jan 1;156(1):76-90. doi: 10.1001/jamasurg.2020.5045. Erratum In: JAMA Surg. 2021 Apr 1;156(4):403.
- Chihuri S, Li G. Use of prescription opioids and motor vehicle crashes: A meta analysis. Accid Anal Prev. 2017 Dec;109:123-131. doi: 10.1016/j.aap.2017.10.004. Epub 2017 Oct 20.
- Rabbitts JA, Kain Z. Perioperative Care for Adolescents Undergoing Major Surgery: A Biopsychosocial Conceptual Framework. Anesth Analg. 2019 Oct;129(4):1181-1184. doi: 10.1213/ANE.0000000000004048. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2022
Primary Completion (Actual)
October 11, 2023
Study Completion (Actual)
October 15, 2023
Study Registration Dates
First Submitted
July 20, 2022
First Submitted That Met QC Criteria
July 28, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-019982
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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