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

Injection Site Irritation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378113
• Other study ID #: STUDY00001599
• Status: Recruiting
• Phase: Phase 2
• Start date: May 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: Vipin Bansal, MD
• Phone: 404-785-6670
• Email: vipin.bansal[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Injection Site Irritation

Intervention

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

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in verbal rating scale (VRS) form baseline	Difference in total VRS between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain.	Baseline, during propofol injection (30 seconds)
Primary	Change in Motor score scale from baseline	Change in Motor score between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain.	Baseline, during propofol injection (30 seconds)