Opioid-free anesthesia for kids undergoing tonsil surgery
Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
This study is testing if a new anesthesia method that doesn't use opioids can help kids have tonsil surgery with less pain and quicker recovery compared to the usual opioid-based method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT06326983 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an opioid-sparing anesthesia plan compared to a traditional opioid-based plan for pediatric patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The study is a prospective, randomized, controlled, non-inferiority trial that aims to assess perioperative analgesia and recovery time. Secondary outcomes include the need for rescue opioids, incidence of emergence delirium, post-operative nausea and vomiting, and other intraoperative measures. The goal is to determine if the opioid-sparing approach can provide similar or better outcomes without the risks associated with opioid use.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 17 scheduled for tonsillectomy or tonsillotomy at Boston Children's Hospital Waltham.
Not a fit: Patients not undergoing primary tonsillectomy/tonsillotomy or those with certain medical conditions, such as coagulopathies or chronic pain syndromes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce opioid use in pediatric patients, minimizing the risk of opioid-related side effects.
How similar studies have performed: Other studies have shown promising results with opioid-sparing techniques in various surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesia classification status I-III * Ages 3 years to 17 years * Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham Exclusion Criteria: * Patients not scheduled for primary tonsillectomy/tonsillotomy. * Patients with known coagulopathies * Patients with previous chronic pain syndromes * Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
Where this trial is running
Waltham, Massachusetts
- Boston Children's Hospital — Waltham, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jocelyn Booth, BSN
- Email: jocelyn.booth@childrens.harvard.edu
- Phone: 857-218-4585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.