Using Ondansetron to Reduce Pain from Propofol Injections in Children
Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
This study is testing if giving ondansetron before propofol injections can help reduce pain in children aged 2-17 who are having surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05378113 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering ondansetron (Zofran) before propofol injections can reduce pain in pediatric patients undergoing surgery. The study is randomized and single-site, taking place at Children's Healthcare of Atlanta at Egleston. Participants aged 2-17 will be assigned to receive either Zofran or lidocaine, the standard care for pain management. A blinded observer will assess pain levels during the injection, and vital signs will be monitored throughout the procedure.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2-17 undergoing surgery with peripheral vascular access.
Not a fit: Patients with chronic pain syndromes or those undergoing endoscopy procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for children receiving anesthesia.
How similar studies have performed: Previous studies in adults have shown that ondansetron can effectively reduce pain associated with propofol injections, suggesting potential success in this pediatric application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 2 years old through 17 years of age * Children undergoing surgery at Children's Healthcare of Atlanta Egleston location * Patient with existing peripheral vascular access in the arm below the antecubital fossa * Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3 * Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent * No known chronic pain syndrome Exclusion Criteria: * Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent * Patients presenting for endoscopy procedures * Known chronic pain syndrome * Patient diagnosed with long QT syndrome * Patient weighing \>40kg * Documented allergy to study medications * Pain on injection of pre-operative normal saline flush * Patient has received an opioid within 30 minutes prior to anesthesia induction
Where this trial is running
Atlanta, Georgia
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Vipin Bansal, MD — Emory University
- Study coordinator: Vipin Bansal, MD
- Email: vipin.bansal@emory.edu
- Phone: 404-785-6670
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.