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Metoclopramide Versus Ketorolac for Tension-type Headache

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011673
First Posted: November 11, 2009
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
  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 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute tension type headache

Exclusion Criteria:

  • Contraindications to investigational medications
  • Secondary cause of headache
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011673


Locations
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011673     History of Changes
Other Study ID Numbers: ED treatment of ETTH
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: November 3, 2012
Results First Posted: December 3, 2012
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Benjamin Friedman, 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
Ketorolac
Ketorolac Tromethamine
Diphenhydramine
Metoclopramide
Promethazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics