Metoclopramide Versus Ketorolac for Tension-type Headache

This study has been completed.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center Identifier:
First received: November 9, 2009
Last updated: December 5, 2012
Last verified: December 2012
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
Drug: Metoclopramide
Drug: Ketorolac
Phase 4

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:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Change in Pain Score [ Time Frame: Baseline, 60 minutes ] [ Designated as safety issue: No ]
    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:
  • Satisfaction Scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

Enrollment: 123
Study Start Date: November 2009
Study Completion Date: November 2012
Primary Completion Date: September 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


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

Inclusion Criteria:

  • Acute tension type headache

Exclusion Criteria:

  • Contraindications to investigational medications
  • Secondary cause of headache
  Contacts and Locations
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Please refer to this study by its identifier: NCT01011673

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center Identifier: NCT01011673     History of Changes
Other Study ID Numbers: ED treatment of ETTH 
Study First Received: November 9, 2009
Results First Received: November 3, 2012
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
tension-type headache

Additional relevant MeSH terms:
Tension-Type Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Anesthetics, Local
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Dermatologic Agents
Dopamine Agents processed this record on May 26, 2016