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Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

ConditionsSurgeryPain, Post Operative
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-20
SponsorUniversity of Michigan

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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

  • 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)

  • 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)

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Acetaminophen/NSAID regimenOther 2 interventions
Group B: Acetaminophen/NSAID/Opioid regimenOther 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days post-surgery, and up to 12 months after surgery
2

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.

Time frame
14 days post-surgery, and 1 month after surgery

Secondary outcomes

1

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

This is a 4-question survey in which participants will rate statements pertaining to quality of sleep. Participants will also rate sleep quality as very poor (5), poor (4), fair (3), good (2), or very good (1).

Time frame
Baseline and 1 month after surgery
2

Patient Global Impression of Change (PGIC)

The perception of improvement or worsening after treatment will be assessed by the patient global impression of change PGIC (range 0-7).

Time frame
Day 7 up to 12 months after surgery
3

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

This is an 8-question survey in which participants will rate statements pertaining to how pain interferes with activities and function.

Time frame
Baseline up to 12 months after surgery
4

Pain Catastrophizing Scale (PCS)

This is a 6-question survey in which participants will rate statements pertaining to their experience of pain.

Time frame
Baseline up to 12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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