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Metoclopramide Versus Ketorolac for Tension-type Headache

Primary Purpose

Headache

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide
Ketorolac
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring headache, tension-type headache

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute tension type headache

Exclusion Criteria:

  • Contraindications to investigational medications
  • Secondary cause of headache

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketorolac

Metoclopramide

Arm Description

Ketorolac 30mg IVSS

metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction Scores
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.

Full Information

First Posted
November 9, 2009
Last Updated
April 15, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01011673
Brief Title
Metoclopramide Versus Ketorolac for Tension-type Headache
Official Title
An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
headache, tension-type headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac 30mg IVSS
Arm Title
Metoclopramide
Arm Type
Active Comparator
Arm Description
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Intervention Description
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
ketorolac 30mg IVSS
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
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
Time Frame
Baseline, 60 minutes
Secondary Outcome Measure Information:
Title
Satisfaction Scores
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute tension type headache Exclusion Criteria: Contraindications to investigational medications Secondary cause of headache
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23567060
Citation
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.
Results Reference
derived

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Metoclopramide Versus Ketorolac for Tension-type Headache

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