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Local Anesthetic
Ondansetron + Lidocaine for Injection Site Reaction
Phase 2
Recruiting
Led By Vipin Bansal, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 2 years old through 17 years of age
Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, during propofol injection (30 seconds)
Awards & highlights
Study Summary
This trial will compare whether Zofran or lidocaine reduces pain better when injected before propofol in pediatric patients.
Who is the study for?
This trial is for children aged 2-17 undergoing surgery at Children's Healthcare of Atlanta Egleston, with a working IV in their arm and an ASA score of 1-3. They must not have chronic pain syndromes, long QT syndrome, weigh over 40kg, allergies to the study meds, or have taken opioids within 30 minutes before anesthesia.Check my eligibility
What is being tested?
The trial is testing if Zofran (Ondansetron) given before propofol can reduce injection pain compared to Lidocaine. It's a randomized study where kids are put into one of these two treatment groups by chance.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site or allergic reactions. Since Ondansetron and Lidocaine are commonly used drugs, significant side effects are rare but will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 17 years old.
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My health is good to moderately impaired according to the ASA score.
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I have a catheter or IV line placed in my arm below the elbow.
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I do not have a chronic pain condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, during propofol injection (30 seconds)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, during propofol injection (30 seconds)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Motor score scale from baseline
Change in verbal rating scale (VRS) form baseline
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ondansetron premedication GroupExperimental Treatment1 Intervention
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 II: Lidocaine premedication GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron
2011
Completed Phase 4
~4010
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,576 Total Patients Enrolled
Vipin Bansal, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My parent or guardian agrees to participate and can sign the consent form.I weigh more than 40kg.I feel pain when given a saline shot before surgery.I am between 2 and 17 years old.My health is good to moderately impaired according to the ASA score.I am scheduled for an endoscopy procedure.I was given an opioid before anesthesia was started.I have a long-term pain condition.I have a catheter or IV line placed in my arm below the elbow.I do not have a chronic pain condition.I have been diagnosed with long QT syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Ondansetron premedication Group
- Group 2: Lidocaine premedication Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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