Clinical trial NCT05378113: Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Official title: Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Injection Site Irritation
Keywords: Injection site pain
Propofol
Ondansetron
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in verbal rating scale (VRS) form baseline
timeFrame: Baseline, during propofol injection (30 seconds)
measure: Change in Motor score scale from baseline
timeFrame: Baseline, during propofol injection (30 seconds)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Vipin Bansal, MD
role: PRINCIPAL_INVESTIGATOR
References: