RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-18
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05378113

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients 2 years old through 17 years of age
  2. * Children undergoing surgery at Children's Healthcare of Atlanta Egleston location
  3. * Patient with existing peripheral vascular access in the arm below the antecubital fossa
  4. * Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3
  5. * Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
  6. * No known chronic pain syndrome
  1. * Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
  2. * Patients presenting for endoscopy procedures
  3. * Known chronic pain syndrome
  4. * Patient diagnosed with long QT syndrome
  5. * Patient weighing \>40kg
  6. * Documented allergy to study medications
  7. * Pain on injection of pre-operative normal saline flush
  8. * Patient has received an opioid within 30 minutes prior to anesthesia induction

Contacts and Locations

Study Contact

Vipin Bansal, MD
CONTACT
404-785-6670
vipin.bansal@emory.edu

Principal Investigator

Vipin Bansal, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Emory University

  • Vipin Bansal, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-18
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-05-18
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Injection site pain
  • Propofol
  • Ondansetron

Additional Relevant MeSH Terms

  • Injection Site Irritation