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Metoclopramide Versus Ketorolac for Tension-type Headache

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ClinicalTrials.gov Identifier: NCT01011673
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : December 3, 2012
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Headache
Interventions Drug: Metoclopramide
Drug: Ketorolac
Enrollment 123
Recruitment Details Patients were recruited from one emergency department (ED) in the Bronx, NY
Pre-assignment Details  
Arm/Group Title Ketorolac Metoclopramide
Hide 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 [1] 60 [2]
Not Completed 2 1
Reason Not Completed
Secondary headache             2             1
[1]
2 patients were randomized but not included in analyses bc they did not truly meet study criteria.
[2]
1 patient was randomized but not included in analyses bc they did not truly meet study criteria.
Period Title: Emergency Department Portion
Started 60 60
Completed 60 60
Not Completed 0 0
Period Title: 24 Hour Follow-up
Started 60 60
Completed 57 57
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             3             3
Arm/Group Title Ketorolac Metoclopramide Total
Hide 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 Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
60
 100.0%
120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
37  (10) 39  (12) 38  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
48
  80.0%
42
  70.0%
90
  75.0%
Male
12
  20.0%
18
  30.0%
30
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Change in Pain Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Ketorolac 30 mg, administered intravenously over 15 minutes
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Overall Number of Participants Analyzed 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (2.6) 5.1  (2.8)
2.Secondary Outcome
Title Satisfaction Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
3 patients in each group were lost to follow-up. All others are tabulated here.
Arm/Group Title Ketorolac Metoclopramide
Hide Arm/Group Description:
Ketorolac 30 mg, administered intravenously over 15 minutes
metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: participants
45 53
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Metoclopramide
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Metoclopramide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ketorolac Metoclopramide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/60 (23.33%)      12/60 (20.00%)    
Gastrointestinal disorders     
Nausea *  2/60 (3.33%)  2 1/60 (1.67%)  1
Epigastric pain *  1/60 (1.67%)  1 1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders     
musculoskeletal pain *  1/60 (1.67%)  1 1/60 (1.67%)  1
Nervous system disorders     
Akathisia   8/60 (13.33%)  8 8/60 (13.33%)  8
Dizziness *  2/60 (3.33%)  2 2/60 (3.33%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin Friedman, MD
Organization: Montefiore Medical Center, Albert Einstein College of Medicine
Phone: 718-920-6626
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01011673     History of Changes
Other Study ID Numbers: 09-08-249
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: May 15, 2018