Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

NCT06671002 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: HUM00252793BPS-2023C1-32147
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

Brief Summary

This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?

Conditions

Surgery; Pain, Post Operative

Keywords

Medications after surgery; NSAIDS; Acetaminophen; Opioids; Analgesics, non-narcotic; Tonsil removal; Gallbladder removal; Knee scope; Analgesics, opioid

Outcome Measures

Primary Outcomes (2)

• Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery

  This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.

  14 days post-surgery, and up to 12 months after surgery

• Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery

  Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 14 days post-surgery.

  14 days post-surgery, and 1 month after surgery

Secondary Outcomes (16)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a

  Baseline and 1 month after surgery

• Patient Global Impression of Change (PGIC)

  Day 7 up to 12 months after surgery

• PROMIS Pediatric Pain Interference scale (Short form-8a)

  Baseline up to 12 months after surgery

• Pain Catastrophizing Scale (PCS)

  Baseline up to 12 months after surgery

• Pediatric Quality of Life Inventory Short Form 15

  Baseline up to 12 months after surgery

Study Arms (2)

Acetaminophen/NSAID regimen

OTHER

Drug: NSAID; Drug: Acetaminophen

Acetaminophen/NSAID/Opioid regimen

OTHER

Drug: Opioid; Drug: Acetaminophen; Drug: Ibuprofen

Interventions

NSAID DRUG

Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain: * Ibuprofen 10 milligrams(mg)/kilogram (kg) (maximum 600mg) by mouth every 6 hours around the clock for 2 days, then as needed for pain thereafter (40 doses) * Celecoxib 6mg/kg (maximum 400mg) by mouth once then 3 mg/kg (maximum 200mg) every 12 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)

Also known as: Ibuprofen, Celecoxib

Acetaminophen/NSAID regimen

Opioid DRUG

Once randomized to this group the surgical team will elect to prescribe for 1 of the following treatment options to be given post procedure for post-discharge pain: * Oxycodone 0.1 mg/kg (maximum 5 mg) by mouth every 4 to 6 hours as needed for pain, number 10 doses. * Hydromorphone 0.04 mg/kg (maximum mg) by mouth 4 to 6 hours as needed, number 10 doses

Also known as: Oxycodone, Hydromorphone

Acetaminophen/NSAID/Opioid regimen

Acetaminophen DRUG

Participants will receive 15mg/kg up to 1000mg by mouth every 6 hours around the clock for the first 2 days after discharge from surgery then as needed thereafter (40 doses)

Acetaminophen/NSAID regimen; Acetaminophen/NSAID/Opioid regimen

Ibuprofen DRUG

Ibuprofen 10mg/kg (maximum 600 mg) by mouth every 6 hours around the clock for 2 days after discharge from surgery then as needed thereafter (40 doses)

Acetaminophen/NSAID/Opioid regimen

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6 days or more of opioid medications in the past 90 days (aligning with American Pediatric Guidelines that were published in September 2024 after the project was funded), excepting surgical team prescriptions within the week of surgery.
• Undergo one the following: tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).

You may not qualify if:

• Anticipated other surgery within 12 months
• Anticipated life expectancy of \<12 months
• Those that have legal guardians (due to special permission to enroll in trials)
• Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
• Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
• Liver disease
• Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• University of Michigan: lead

Study Sites (4)

Children's Hospital Los Angeles (CHLA)

Los Angeles, California, 90027, United States

RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Nationwide Children's (NCH)

Columbus, Ohio, 43205, United States

RECRUITING

Related Links

• Project Summary on pcori.org

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Celecoxib; Analgesics, Opioid; Oxycodone; Hydromorphone; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Central Nervous System Agents; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Mark Bicket, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Clark

CONTACT

734-232-0324; sarahmcl@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Anticipated summer 2029 with no end date
• Access Criteria: Investigators can access the IPD and supporting information for analyses related to aims in the proposal. The proposed used of the data needs to be approved by a review committee and the sponsor. Proposals may be submitted up to 36 months after data availability, after which data will be available in a data warehouse but without investigator support.

Locations

US (4)