Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Contro… (NCT05378113) | Clinical Trial Compass
TerminatedPhase 2
Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Stopped: Study was terminated due to enrollment challenges following the relocation of orthopedic procedures to a different hospital.
United States6 participantsStarted 2023-05-18
Plain-language summary
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. The investigators want to see if in pediatric patients, giving Zofran prior to propofol, reduces the pain that patients often experience when propofol is injected through an IV. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. The investigators hope to show a means of improving pain control in their patients undergoing anesthesia.
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Verbal Rating Scale (VRS)
Timeframe: Baseline, during propofol injection (30 seconds)
2
Motor Score Scale
Timeframe: Baseline, during propofol injection (30 seconds)