Ondansetron for Injection Site Irritation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Children's Healthcare of Atlanta, Atlanta, GA
Injection Site Irritation
Ondansetron - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Injection Site Irritation

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline, during propofol injection (30 seconds)

Baseline, during propofol injection (30 seconds)
Change in Motor score scale from baseline
Change in verbal rating scale (VRS) form baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Injection Site Irritation

Side Effects for

Ondansetron
2%Deep Vein Thrombosis
2%Cerebrospinal fluid leak
2%Fever
0%Cerebrovascular Hematoma
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Deep Vein Thrombosis with 2%, Cerebrospinal fluid leak with 2%, Fever with 2%, Cerebrovascular Hematoma with 0%.

Trial Design

2 Treatment Groups

Lidocaine premedication Group
1 of 2
Ondansetron premedication Group
1 of 2
Active Control
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Ondansetron · No Placebo Group · Phase 2

Ondansetron premedication Group
Drug
Experimental Group · 1 Intervention: Ondansetron · Intervention Types: Drug
Lidocaine premedication Group
Drug
ActiveComparator Group · 1 Intervention: Lidocaine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron
2011
Completed Phase 4
~4010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, during propofol injection (30 seconds)

Trial Background

Prof. VBansal, Assistant Professor
Principal Investigator
Emory University
Closest Location: Children's Healthcare of Atlanta · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2006First Recorded Clinical Trial
1 TrialsResearching Injection Site Irritation
203 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Children undergoing surgery at Children's Healthcare of Atlanta Egleston location.
You have a patient with an existing peripheral vascular access in the arm below the antecubital fossa.
You have an ASA physical status of 1, 2 or 3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.