Status:
RECRUITING
Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Lead Sponsor:
Emory University
Conditions:
Injection Site Irritation
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief 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...
Detailed Description
Propofol is a drug commonly used at the beginning of anesthesia (induction). Patients often experience discomfort when propofol is injected through an IV. Ondansetron (Zofran) is a drug that is common...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05378113
Start Date
May 18 2023
End Date
December 1 2025
Last Update
February 27 2025
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322