Metoclopramide Versus Ketorolac for Tension-type Headache

NCT ID: NCT01011673

Last Updated: 2018-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac

Ketorolac 30mg IVSS

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

ketorolac 30mg IVSS

Metoclopramide

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Interventions

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Metoclopramide

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Intervention Type DRUG

Ketorolac

ketorolac 30mg IVSS

Intervention Type DRUG

Other Intervention Names

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Reglan Toradol

Eligibility Criteria

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Inclusion Criteria

* Acute tension type headache

Exclusion Criteria

* Contraindications to investigational medications
* Secondary cause of headache
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin W. Friedman, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.

Reference Type DERIVED
PMID: 23567060 (View on PubMed)

Other Identifiers

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09-08-249

Identifier Type: -

Identifier Source: org_study_id

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