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

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.

Study Overview

• Status: Terminated
• Conditions: Injection Site Irritation
• Intervention / Treatment: Drug: Ondansetron; Drug: Lidocaine

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 commonly used to treat nausea after anesthesia. In adult studies, it has been shown that there is significantly less pain when Zofran is given just before propofol is given. The investigators want to see if giving Zofran prior to propofol reduces the pain and discomfort experienced by pediatric patients.

This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. During induction the treating anesthesiologist will be blinded to the study arm, however they will be unblinded at the end of induction. All subjects will receive Zofran at some point during the surgery - for patients not in the Zofran arm, they will receive it at the end of the case as usual. A blinded observer will score the subject's pain during propofol injection and vital signs will be recorded.

Subjects will be identified by the study team from the surgery schedule. Patients ages 2-17 undergoing surgery with peripheral vascular access (an IV) will be approached. Consent and assent (when appropriate) will be obtained. Subjects will not be compensated. Participation will consist only of the single duration of the surgery.

In this study the investigators hope to show a means of improving pain control in their patients undergoing anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ondansetron premedication Group; 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; Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.; Other Names: Zofran, Ondansetron hydrochloride
Active Comparator: Lidocaine premedication Group; 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; 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.; Other Names: Xylocaine, lidocaine hydrochloride (HCl) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Vipin Bansal, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; Ondansetron; Injection site pain
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Indoles; Heterocyclic Compounds, 3-Ring; Carbazoles; Lidocaine; Ondansetron; Injections
• Other Study ID Numbers: STUDY00001599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No