Metoclopramide Versus Ketorolac for Tension-type Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01011673
First received: November 9, 2009
Last updated: December 5, 2012
Last verified: December 2012
  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
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

  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
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 ClinicalTrials.gov identifier: NCT01011673

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

No publications provided by Montefiore Medical Center

Additional 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
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:
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 28, 2014