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

NCT05378113 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STUDY00001599
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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

Keywords

Injection site pain; Propofol; Ondansetron

Outcome Measures

Primary Outcomes (2)

• Verbal Rating Scale (VRS)

  VRS will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no verbal indication of pain, 1 refers to purposeless moaning, 2 refers to explicit protest and 3 refers to screaming/crying of pain. Higher scores indicate a higher level of perceived pain/distress.

  Baseline, during propofol injection (30 seconds)

• Motor Score Scale

  Motor score scale will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no movement, 1 refers to slight hand withdrawal, 2 refers to marked withdrawal, rubbing, trying to tear off the line and 3 refers to general restlessness. Higher scores indicate a more severe motor withdrawal response and higher perceived pain or distress.

  Baseline, during propofol injection (30 seconds)

Study Arms (2)

Ondansetron premedication Group

EXPERIMENTAL

The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.

Drug: Ondansetron

Lidocaine premedication Group

ACTIVE COMPARATOR

The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.

Drug: Lidocaine

Interventions

Ondansetron DRUG

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

Also known as: Zofran, Ondansetron hydrochloride

Ondansetron premedication Group

Lidocaine DRUG

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.

Also known as: Xylocaine, lidocaine hydrochloride (HCl) Injection

Lidocaine premedication Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Ondansetron; Lidocaine; Injections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Vipin Bansal
• Organization: Emory University

vipin.bansal@emory.edu

404-630-9552

Study Officials

• Vipin Bansal, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: May 18, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)