drugset / Trial / NCT02735343

The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine

NCT02735343

Phase 3 Terminated 5 enrolled Mike O'Callaghan Military Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.

Timeline

Start
2016-08
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.3 mg/kg Intravenous
Comparator Prochlorperazine Small molecule 10 mg Intravenous
Background Diphenhydramine Unknown 25 mg Intravenous
Background Ondansetron Other / unclassified 4 mg Intravenous

Indications