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drugset / Trial / NCT05378113

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

NCT05378113 ↗

Phase 2 Terminated 6 enrolled Emory University
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2023-05-18
Primary completion
2023-08-03
Completion
2023-08-03

Outcome

Outcome not reported

Stopped (Enrollment): “Study was terminated due to enrollment challenges following the relocation of orthopedic procedures to a different hospital.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 1 mg/kg Intravenous
Subject Ondansetron Other / unclassified 0.15 mg/kg Intravenous

Indications

No indication recorded.