Metoclopramide Versus Ketorolac for Tension-type Headache

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01011673
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Headache	Drug: Metoclopramide; Drug: Ketorolac	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketorolac Ketorolac 30mg IVSS	Drug: Ketorolac; ketorolac 30mg IVSS; Other Names: Toradol
Active Comparator: Metoclopramide metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS	Drug: Metoclopramide; metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS; Other Names: Reglan

Outcome Measures

Primary Outcome Measures

1. Change in Pain Score [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

1. Satisfaction Scores [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 64 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT01011673
• Other Study ID Numbers: 09-08-249
• First Posted: Nov 11, 2009
• Last Update Posted: May 15, 2018
• Last Verified: Apr 1, 2018

• 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
• Keywords provided by Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center: headache; tension-type headache
• Additional relevant MeSH terms: Tension-Type Headache; Headache; Ketorolac; Metoclopramide

Study Results

Participant Flow

Recruitment Details	Patients were recruited from one emergency department (ED) in the Bronx, NY

Arm/Group Title	Ketorolac	Metoclopramide
Arm/Group Description	Ketorolac 30 mg, administered intravenously over 15 minutes	metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Period Title: Randomized
STARTED	62	61
COMPLETED	60	60
NOT COMPLETED	2	1
Period Title: Randomized
STARTED	60	60
COMPLETED	60	60
NOT COMPLETED	0	0
Period Title: Randomized
STARTED	60	60
COMPLETED	57	57
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Ketorolac	Metoclopramide	Total
Arm/Group Description	Ketorolac 30 mg, administered intravenously over 15 minutes	metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes	Total of all reporting groups
Overall Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	60 100%	120 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (10)	39 (12)	38 (11)
Sex: Female, Male (Count of Participants)
Female	48 80%	42 70%	90 75%
Male	12 20%	18 30%	30 25%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	120 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.

Arm/Group Title	Ketorolac	Metoclopramide
Arm/Group Description	Ketorolac 30 mg, administered intravenously over 15 minutes	metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Measure Participants	60	60
Mean (Standard Deviation) [units on a scale]	3.8 (2.6)	5.1 (2.8)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

3 patients in each group were lost to follow-up. All others are tabulated here.

Arm/Group Title	Ketorolac	Metoclopramide
Arm/Group Description	Ketorolac 30 mg, administered intravenously over 15 minutes	metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Measure Participants	57	57
Number [participants]	45 75%	53 88.3%

Adverse Events

Arm/Group Title	Ketorolac		Metoclopramide
Arm/Group Description	Ketorolac 30 mg, administered intravenously over 15 minutes		metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
All Cause Mortality
	Ketorolac		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketorolac		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Ketorolac		Metoclopramide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/60 (23.3%)		12/60 (20%)
Gastrointestinal disorders
Nausea	2/60 (3.3%)	2	1/60 (1.7%)	1
Epigastric pain	1/60 (1.7%)	1	1/60 (1.7%)	1
Musculoskeletal and connective tissue disorders
musculoskeletal pain	1/60 (1.7%)	1	1/60 (1.7%)	1
Nervous system disorders
Akathisia	8/60 (13.3%)	8	8/60 (13.3%)	8
Dizziness	2/60 (3.3%)	2	2/60 (3.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.