Metoclopramide Versus Ketorolac for Tension-type Headache
An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache
1 other identifier
interventional
123
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
December 3, 2012
CompletedMay 15, 2018
April 1, 2018
2.8 years
November 9, 2009
November 3, 2012
April 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Score
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
Baseline, 60 minutes
Secondary Outcomes (1)
Satisfaction Scores
24 hours
Study Arms (2)
Ketorolac
ACTIVE COMPARATORKetorolac 30mg IVSS
Metoclopramide
ACTIVE COMPARATORmetoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
Interventions
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
Eligibility Criteria
You may qualify if:
- Acute tension type headache
You may not qualify if:
- Contraindications to investigational medications
- Secondary cause of headache
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (1)
Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.
PMID: 23567060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin Friedman, MD
- Organization
- Montefiore Medical Center, Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 11, 2009
Study Start
November 1, 2009
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
May 15, 2018
Results First Posted
December 3, 2012
Record last verified: 2018-04