Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Официальное название

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

Обзор

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?

Вмешательства

• Препарат NSAID
  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)
• Препарат Opioid
  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
• Препарат Acetaminophen
  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)
• Препарат Ibuprofen
  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)

Первичные конечные точки

• Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery [Срок оценки: 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 [Срок оценки: 14 days post-surgery, and 1 month after surgery]

Вторичные конечные точки (12)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a [Срок оценки: Baseline and 1 month after surgery]
• Patient Global Impression of Change (PGIC) [Срок оценки: Day 7 up to 12 months after surgery]
• PROMIS Pediatric Pain Interference scale (Short form-8a) [Срок оценки: Baseline up to 12 months after surgery]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline up to 12 months after surgery]
• Pediatric Quality of Life Inventory Short Form 15 [Срок оценки: Baseline up to 12 months after surgery]
• Quality of Recovery (QoR) 15 [Срок оценки: Day 3, 1 week, and 2 weeks after surgery]
• Patient Health Questionnaire (PHQ-2) [Срок оценки: Baseline up to 12 months after surgery]
• Generalized Anxiety Disorder (GAD-2) [Срок оценки: Baseline up to 12 months after surgery]
• Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use [Срок оценки: Baseline up to 12 months after surgery]
• National Survey on Drug Use and Health Questions on Opioid Misuse [Срок оценки: Baseline up to 12 months after surgery]
• New prolonged opioid use [Срок оценки: Up to 12 months after surgery]
• Acute pain based on The Michigan Body Map [Срок оценки: Up to 12 months after surgery]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Children's Hospital Los Angeles (CHLA) — Los Angeles
• Lucile Packard Children's Hospital Stanford — Palo Alto
• University of Michigan — Ann Arbor
• Nationwide Children's (NCH) — Columbus

Публикации

• Lee JS, Bicket MC, Mansfield SA, Rabbitts JA, Van Horn A, Perrone EE, Chua KP, Voepel-Lewis T, Waljee J, Brummett C, Hutmacher C, Li Y, Kelley-Quon LI; CARES for Kids Investigators. US multicentre randomised controlled trial protocol: Comparing Analgesic Regimen Effectiveness and Safety after surgery trial for Kids (CARES for Kids). BMJ Open. 2026 May 28;16(5):e118728. doi: 10.1136/bmjopen-2026-11 PMID 42208996

Идентификаторы

NCT: NCT06671002 · HUM00252793 · BPS-2023C1-32147

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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