Ondansetron for Injection Site Irritation
Phase-Based Progress Estimates
Effectiveness
Safety
Children's Healthcare of Atlanta, Atlanta, GA
Injection Site Irritation
Ondansetron - DrugEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
What conditions do you have?
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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
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
This is further along than 68% of similar trials
Side Effects for
Ondansetron
2%Deep Vein Thrombosis
2%Cerebrospinal fluid leak
2%Fever
0%Cerebrovascular Hematoma
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: DrugLidocaine premedication Group
Drug
ActiveComparator Group · 1 Intervention: Lidocaine · Intervention Types: DrugTreatment
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
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 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.
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Conditions
Cancer Related
Treatments