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

NCT ID: NCT05378113

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Injection Site Irritation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: 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.

Interventions

Ondansetron

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zofran, Ondansetron hydrochloride; Xylocaine, lidocaine hydrochloride (HCl) Injection

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

VBansal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vipin Bansal, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vipin Bansal, MD

Role: CONTACT

vipin.bansal@emory.edu

404-785-6670

Facility Contacts

Vipin Bansal, MD

Role: primary

vipin.bansal@emory.edu

404-785-6670

Other Identifiers

STUDY00001599

Identifier Type: -

Identifier Source: org_study_id