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

Description

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.

Conditions

Injection Site Irritation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Injection Site Irritation
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Vipin Bansal, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2024-12