Metoclopramide Versus Ketorolac for Tension-type Headache

Phase 4

Completed

• Conditions: Headache
• Interventions: Drug: Ketorolac; Drug: Metoclopramide

• Registration Number: NCT01011673
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Results First Submitted: 2012-11-03
• Results First Submitted QC: 2012-11-03
• Results First Posted: 2012-12-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Acute tension type headache

Exclusion Criteria

• Contraindications to investigational medications
• Secondary cause of headache

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	Ketorolac 30mg IVSS
Metoclopramide	Metoclopramide	metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	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 Outcome Measures

Name	Time	Method
Satisfaction Scores	24 hours	24 hours after the emergency department visit, patients were asked, "The next time you come to the Er with this type of headache, do you want to receive the same medication?" Affirmative answers are tabulated here.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States