Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial
概览
- 阶段
- 4 期
- 干预措施
- NSAID
- 疾病 / 适应症
- 未指定
- 发起方
- University of Michigan
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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?
研究者
Mark Bicket, MD, PhD
Associate Professor of Anesthesiology
University of Michigan
入排标准
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
Acetaminophen/NSAID regimen
干预措施: NSAID
Acetaminophen/NSAID regimen
干预措施: Acetaminophen
Acetaminophen/NSAID/Opioid regimen
干预措施: Opioid
Acetaminophen/NSAID/Opioid regimen
干预措施: Acetaminophen
Acetaminophen/NSAID/Opioid regimen
干预措施: Ibuprofen
结局指标
主要结局
Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Quality of Recovery (QoR) 15(Day 3, 1 week, and 2 weeks after surgery)
- New prolonged opioid use(Up to 12 months after surgery)
- Patient Health Questionnaire (PHQ-2)(Baseline up to 12 months after surgery)
- Generalized Anxiety Disorder (GAD-2)(Baseline up to 12 months after surgery)
- Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use(Baseline up to 12 months after surgery)
- National Survey on Drug Use and Health Questions on Opioid Misuse(Baseline up to 12 months after surgery)
- Acute pain based on The Michigan Body Map(Up to 12 months after surgery)
- Chronic pain based on Body Map(Up to 12 months after surgery)
- Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery(to 12 months after surgery)
- Healthcare Utilization related to pain(Up to 12 months after surgery)
- Analgesic medication use(Up to 12 months after surgery)