RecruitingPhase 2NCT05378113

Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial

Sponsor

Emory University

Enrollment

120 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Injection Site Irritation

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Inclusion Criteria6

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 Criteria8

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

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Interventions

DRUGOndansetron

Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.

DRUGLidocaine

Lidocaine is a local anesthetic agent used intravenously prior to the propofol injection. Currently the standard of care to help decrease the severity of pain in the injection site, a common side effect of propofol.

Locations(1)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT05378113