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Clinical Trials/NCT01011673
NCT01011673
Completed
Phase 4

An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache

Montefiore Medical Center1 site in 1 country123 target enrollmentNovember 2009

Overview

Phase
Phase 4
Intervention
Ketorolac
Conditions
Headache
Sponsor
Montefiore Medical Center
Enrollment
123
Locations
1
Primary Endpoint
Change in Pain Score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
November 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benjamin W. Friedman, MD

Associate professor

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • Acute tension type headache

Exclusion Criteria

  • Contraindications to investigational medications
  • Secondary cause of headache

Arms & Interventions

Ketorolac

Ketorolac 30mg IVSS

Intervention: Ketorolac

Metoclopramide

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Intervention: Metoclopramide

Outcomes

Primary Outcomes

Change in Pain Score

Time Frame: Baseline, 60 minutes

At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score

Secondary Outcomes

  • Satisfaction Scores(24 hours)

Study Sites (1)

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