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NCT Number: NCT06671002

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids 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?

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pain, Post Operative Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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)

Treatment and study plan

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)

Other names: Ibuprofen, Celecoxib

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

Other names: Oxycodone, Hydromorphone

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)

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Patient Global Impression of Change (PGIC)

    Time frame: 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).

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

    Time frame: 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.

  4. Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  5. Pediatric Quality of Life Inventory Short Form 15

    Time frame: 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).

  6. Quality of Recovery (QoR) 15

    Time frame: 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.

  7. Patient Health Questionnaire (PHQ-2)

    Time frame: 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.

  8. Generalized Anxiety Disorder (GAD-2)

    Time frame: 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.

  9. Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use

    Time frame: Baseline up to 12 months after surgery

    This is a 6-question survey about the participants' use of tobacco, alcohol and drugs.

  10. National Survey on Drug Use and Health Questions on Opioid Misuse

    Time frame: 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.

  11. New prolonged opioid use

    Time frame: Up to 12 months after surgery

    One question that will assess opioid prescription fills to identify new prolonged opioid use after surgery

  12. Acute pain based on The Michigan Body Map

    Time frame: Up to 12 months after surgery

    Participants will document/mark on this image map to identify areas in which acute pain was felt.

  13. Chronic pain based on Body Map

    Time frame: 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.

  14. Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery

    Time frame: to 12 months after surgery

    One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.

  15. Healthcare Utilization related to pain

    Time frame: 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.

  16. Analgesic medication use

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Clark

CONTACT

[email protected]

734-232-0324

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial

Acronym: CARES for Kids

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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