Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

NCT03221569 PHASE4 UNKNOWN

The hypothesis of the study is that sub-dissociative dose ketamine will prove to be superior to or as standard therapy, ketorolac, in the treatment of acute tension type headache (TTH) as measured by the 10 point Numerical Rating Scale (NRS. The aim of the study is to compare the safety \& efficacy of intravenous sub-dissociative dose ketamine versus ketorolac for acute treatment of migraines in the Emergency Department (ED) The primary endpoints are: Patient perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes. The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at 15, 30, 45, 60, 75, 90 min, Number of emergency department re-visits for acute migraine one month post discharge, incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams) during study period, incidence of nausea, vomiting, or worsening headache, Incidence of bad taste, Incidence of burning sensations in the nostrils, incidence of hypertension, time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale.

Details

Lead sponsor	The Brooklyn Hospital Center
Phase	PHASE4
Status	UNKNOWN
Enrolment	60
Start date	Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Feb 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Migraine

Interventions

• Intravenous ketamine
• Ketorolac
• Normal saline
• Normal saline

Countries

United States