Metoclopramide Versus Ketorolac for Tension-type Headache - Full Text View

Sponsor:	Montefiore Medical Center
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT01011673

Purpose

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.

Condition	Intervention	Phase
Headache	Drug: Metoclopramide Drug: Ketorolac	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Metoclopramide hydrochloride Ketorolac Ketorolac tromethamine Diphenhydramine citrate Diphenhydramine hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Change in pain score [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Satisfaction scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ketorolac Ketorolac 30mg IVSS	Drug: Ketorolac ketorolac 30mg IVSS Other Name: Toradol
Active Comparator: Metoclopramide metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS	Drug: Metoclopramide metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS Other Name: Reglan

Eligibility

Ages Eligible for Study:	21 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute tension type headache

Exclusion Criteria:

Contraindications to investigational medications
Secondary cause of headache

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011673

Contacts

Contact: Benjamin Friedman, MD, MS

718-920-6626

befriedm@montefiore.org

Locations

United States, New York
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin Friedman, MD, MS 718-920-6626 befriedm@montefiore.org

Sponsors and Collaborators

Montefiore Medical Center

More Information

No publications provided

Responsible Party:	Benjamin Friedman, principal investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT01011673 History of Changes
Other Study ID Numbers:	ED treatment of ETTH
Study First Received:	November 9, 2009
Last Updated:	July 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:

headache
tension-type headache

Additional relevant MeSH terms:

Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Diphenhydramine
Metoclopramide
Promethazine
Ketorolac
Ketorolac Tromethamine

Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012