Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Phase 4

Recruiting

• Conditions: Surgery; Pain, Post Operative
• Interventions: Drug: Opioid; Drug: NSAID; Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT06671002
• Lead Sponsor: University of Michigan

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-11-04
• Study Start: 2024-12-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-10-16
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• No significant analgesic medication use before surgery as defined in the protocol
• Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen/NSAID regimen	Acetaminophen	-
Acetaminophen/NSAID/Opioid regimen	Opioid	-
Acetaminophen/NSAID/Opioid regimen	Acetaminophen	-
Acetaminophen/NSAID/Opioid regimen	Ibuprofen	-
Acetaminophen/NSAID regimen	NSAID	-

Primary Outcome Measures

Name	Time	Method
Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery	14 days post-surgery, and up to 12 months after surgery	This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.
Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery	14 days post-surgery, and 1 month after surgery	Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 14 days post-surgery.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a	Baseline and 1 month after surgery	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).
Patient Global Impression of Change (PGIC)	Day 7 up to 12 months after surgery	The perception of improvement or worsening after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
PROMIS Pediatric Pain Interference scale (Short form-8a)	Baseline up to 12 months after surgery	This is an 8-question survey in which participants will rate statements pertaining to how pain interferes with activities and function.
Pain Catastrophizing Scale (PCS)	Baseline up to 12 months after surgery	This is a 6-question survey in which participants will rate statements pertaining to their experience of pain.
Pediatric Quality of Life Inventory Short Form 15	Baseline up to 12 months after surgery	There are 15 questions with four scales for function related to physical, emotional, social, and school dimensions for adolescents. Participants answer questions from never (0) to almost always (4).
Quality of Recovery (QoR) 15	Day 3, 1 week, and 2 weeks after surgery	There are 15 questions assessed on a scale of 1-10, with 0 being none of the time and 10 being all of the time, 10 being the better outcome.
New prolonged opioid use	Up to 12 months after surgery	One question that will assess opioid prescription fills to identify new prolonged opioid use after surgery
Patient Health Questionnaire (PHQ-2)	Baseline up to 12 months after surgery	There are 2 questions that are completed to screen for depression. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of depression.
Generalized Anxiety Disorder (GAD-2)	Baseline up to 12 months after surgery	There are 2 questions that are completed to screen for anxiety. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of anxiety.
Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use	Baseline up to 12 months after surgery	This is a 6-question survey about the participants' use of tobacco, alcohol and drugs.
National Survey on Drug Use and Health Questions on Opioid Misuse	Baseline up to 12 months after surgery	This is a one question survey that assesses opioid misuse defined as use that is more than prescribed, for non pain-related reasons, or in a way not prescribed by a doctor.
Acute pain based on The Michigan Body Map	Up to 12 months after surgery	Participants will document/mark on this image map to identify areas in which acute pain was felt.
Chronic pain based on Body Map	Up to 12 months after surgery	Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery	to 12 months after surgery	One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.
Healthcare Utilization related to pain	Up to 12 months after surgery	Participants will answer questions about their healthcare utilization related to pain for the following three events: (1) postoperative clinical interactions related to pain in the form of patient messages, phone calls, and non-routine clinic visits related to pain, (2) emergency room visits, and (3) hospitalizations. The study team will also review health record for the same events.
Analgesic medication use	Up to 12 months after surgery	Participants will answer questions about their analgesic medication use for acetaminophen, NSAIDs, opioids, and other medications, including prescription fills, over-the-counter use, and consumption. The study team will also review health record for prescription fills.

Trial Locations

Locations (4)

Children's Hospital Los Angeles (CHLA); 🇺🇸 Los Angeles, California, United States

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Nationwide Children's (NCH); 🇺🇸 Columbus, Ohio, United States