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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
Headache Drug: Metoclopramide Drug: Ketorolac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Benjamin Friedman, Montefiore Medical Center:

Primary Outcome Measures:
  • Change in Pain Score [ Time Frame: 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:
  • Satisfaction Scores [ Time Frame: 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.

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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute tension type headache

Exclusion Criteria:

  • Contraindications to investigational medications
  • Secondary cause of headache
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Benjamin Friedman, Montefiore Medical Center:
tension-type headache

Additional relevant MeSH terms:
Tension-Type Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists processed this record on September 21, 2017