Metoclopramide Versus Ketorolac for Tension-type Headache

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011673
• Other study ID #: 09-08-249
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: April 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• Acute tension type headache

Exclusion Criteria:

• Contraindications to investigational medications

• Secondary cause of headache

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Drug:
• Metoclopramide
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
• Ketorolac
ketorolac 30mg IVSS

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score	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	Baseline, 60 minutes
Secondary	Satisfaction Scores	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.	24 hours