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

Phase 2TerminatedNCT05378113

Emory University6 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Conditions

Injection Site Irritation

Interventions

OndansetronDRUG

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

LidocaineDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, during propofol injection (30 seconds)

Data from ClinicalTrials.gov

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