The Adolescent Surgery Experience: A Mixed Methods Analysis

NCT05482919 | Completed

• 1 other identifier: 22-019982
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Pain; Pain, Acute; Pain, Chronic; Adolescent Behavior; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Incidence of new chronic pain

  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 Outcomes (2)

• Prolonged opioid use compared to peers undergoing similar surgeries

  7 months

• Delayed recovery compared to peers

  7 months

Interventions

Baseline Survey BEHAVIORAL

The baseline survey, initial PHQ-9 and GAD-7, could be collected prior to surgery after consent, or on the day of surgery, for participants who are undergoing elective surgery or urgent procedures and did not attend pre-operative clinic. Demographic information such as race and ethnicity, pain medications and pain history and baseline self-reported health information will be collected. It will take about 15 minutes to complete.

Post Operative Surveys BEHAVIORAL

Post operative surveys will be collected at one week, two weeks, one month, then monthly up to 6 months after surgery with total of 7 post-op surveys. Refer to Table 1 for visit windows. The study survey could be collected by phone, REDCap texting or email per the subject's preference. Survey content will also include: daily average and maximum self-reported pain scores on a 0-10 Numeric Rating Scale (NRS) pain scale, average hours of sleep, anxiety and depression screens using the PHQ-9 and GAD-7 questionnaires (Months 1, 3, and 5), pain location and quality, percentage of day spent in pain, satisfaction with recovery using a five-point Likert scale, and type, quantity and timing of any medications used for pain (including opioid alternatives).

Qualitative Interviews BEHAVIORAL

Using sampling to identify adolescents who exhibit higher pain scores or prolonged opioid use compared to peers after completion of the first three surveys (pre-operative, Week 1, Week 2), the study will also select a representative sample of adolescents who are recovering as anticipated. Examples of delayed recovery include a higher proportion of moderate to severe pain scores, dissatisfaction with recovery and prolonged opioid use compared to peers. As a balancing measure, the upper limit of adolescents who are perceived to exhibit delayed recovery that are approached for interviews will be capped at a 3:1 ratio compared to those who are recovering as anticipated, and Investigators will prioritize an equal demographic distribution among the two groups. Interviews will take place over the phone or through a CHOP approved vendor at 1 and 3 months after surgery; audio will be recorded with participant consent.

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (20)

• 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.

  PMID: 26416163 BACKGROUND

• 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.

  PMID: 28363861 BACKGROUND

• 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.

  PMID: 32553622 BACKGROUND

• 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.

  PMID: 33939656 BACKGROUND

• 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.

  PMID: 30810738 BACKGROUND

• 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.

  PMID: 31841589 BACKGROUND

• 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.

  PMID: 18509515 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 32777147 BACKGROUND

• 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.

  PMID: 29203521 BACKGROUND

• 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.

  PMID: 28232147 BACKGROUND

• 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.

  PMID: 23503375 BACKGROUND

• 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.

  PMID: 24290449 BACKGROUND

• 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.

  PMID: 24109194 BACKGROUND

• 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.

  PMID: 26381701 BACKGROUND

• 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.

  PMID: 34874401 BACKGROUND

• 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.

  PMID: 33175130 BACKGROUND

• 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.

  PMID: 29059534 BACKGROUND

• 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.

  PMID: 30720491 BACKGROUND

• Sutherland TN, Hadland SE, Moon J, Fardad J, Ramsay E, Kallan MJ, Neuman MD. The Adolescent Surgery Experience (ASE): a survey-based prospective cohort study to measure risk factors for persistent opioid use. BJA Open. 2025 Oct 15;16:100496. doi: 10.1016/j.bjao.2025.100496. eCollection 2025 Dec.

  PMID: 41142590 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Acute Pain; Chronic Pain; Adolescent Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tori N Sutherland, MD MPH

  CHOP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 1, 2022
• Study Start: June 14, 2022
• Primary Completion: October 11, 2023
• Study Completion: October 15, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (1)