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Valproate Versus Ketorolac Versus Metoclopramide

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ClinicalTrials.gov Identifier: NCT01267864
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : June 4, 2018
Last Update Posted : June 4, 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 Acute Migraine
Interventions Drug: Metoclopramide
Drug: Ketorolac
Drug: Valproate
Enrollment 330
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Period Title: Overall Study
Started 110 110 110
Completed 110 110 110
Not Completed 0 0 0
Arm/Group Title Metoclopramide Ketorolac Valproate Total
Hide Arm/Group Description

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Total of all reporting groups
Overall Number of Baseline Participants 110 110 110 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 110 participants 110 participants 110 participants 330 participants
34
(26 to 44)
34
(25 to 44)
33
(25 to 41)
33
(25 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 110 participants 110 participants 330 participants
Female
92
  83.6%
93
  84.5%
91
  82.7%
276
  83.6%
Male
18
  16.4%
17
  15.5%
19
  17.3%
54
  16.4%
1.Primary Outcome
Title Headache Pain Level on a 0-10 Verbal Scale
Hide Description Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.
Time Frame 60 minutes after receipt of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description:

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Overall Number of Participants Analyzed 110 110 110
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.7
(4.2 to 5.2)
3.9
(3.3 to 4.5)
2.8
(2.3 to 3.3)
2.Secondary Outcome
Title Participants Who Achieve Sustained Headache Freedom for 24 Hours
Hide Description Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication
Time Frame 2- 24 hours after receipt of medication
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that 1 patient in the metoclopramide arm and 1 patient in the ketorolac arm were lost-to-follow-up and did not provide data for this outcome
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description:

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Overall Number of Participants Analyzed 109 109 110
Measure Type: Count of Participants
Unit of Measure: Participants
12
  11.0%
17
  15.6%
4
   3.6%
3.Secondary Outcome
Title Satisfaction With Medication
Hide Description % who answer the following question affirmatively at 24 hours: Do you want to receive the same medication the next time you present to an ER with an acute migraine
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study participants were telephoned 24 hours after medication administration. 3 patients in the metoclopramide arm, 4 in the ketorolac arm, and 3 in the valproate arm were lost to follow-up and did not provide these data. Additionally, 1 patient in the ketorolac arm did not provide an answer to this question
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description:

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Overall Number of Participants Analyzed 107 105 107
Measure Type: Count of Participants
Unit of Measure: Participants
65
  60.7%
42
  40.0%
28
  26.2%
4.Secondary Outcome
Title Adverse Event
Hide Description % who report any adverse event after administration of investigational medication
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Any adverse event reported at any assessment throughout the study period.
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description:

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

Overall Number of Participants Analyzed 109 110 110
Measure Type: Count of Participants
Unit of Measure: Participants
24
  22.0%
33
  30.0%
25
  22.7%
Time Frame Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later.
Adverse Event Reporting Description

Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness.

Also, 1 patient in the metoclopramide arm did not provide any adverse event data.

Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"

 
Arm/Group Title Metoclopramide Ketorolac Valproate
Hide Arm/Group Description

Metoclopramide 10mg IVSS

Metoclorpamide: 10mg IVSS

Ketorolac 30mg IV

Ketorolac: 30g IVSS

1gm IV

Valproate: 1gm IVSS

All-Cause Mortality
Metoclopramide Ketorolac Valproate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metoclopramide Ketorolac Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/109 (0.00%)      0/110 (0.00%)      0/110 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Metoclopramide Ketorolac Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/109 (22.02%)      33/110 (30.00%)      25/110 (22.73%)    
Gastrointestinal disorders       
Dyspepsia *  1/109 (0.92%)  4/110 (3.64%)  2/110 (1.82%) 
Investigations       
Other * [1]  15/109 (13.76%)  15 20/110 (18.18%)  20 17/110 (15.45%)  17
Nervous system disorders       
Restless  [2]  15/109 (13.76%)  15 10/110 (9.09%)  10 9/110 (8.18%)  9
Drowsiness  [3]  2/109 (1.83%)  2 2/110 (1.82%)  2 7/110 (6.36%)  7
Dizzy *  8/109 (7.34%)  8 9/110 (8.18%)  9 6/110 (5.45%)  6
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Any other adverse event
[2]
24 hours after medication administration, we asked patients whether they had felt restless at any time after receiving the IV medication in the ED.
[3]
Too drowsy to function after receiving investigational medication
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin Friedman, MD
Organization: Albert Einstein College of Medicine, Montefiore Medical Center
Phone: 718-920-6626
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01267864     History of Changes
Other Study ID Numbers: 10-01-009
First Submitted: December 15, 2010
First Posted: December 29, 2010
Results First Submitted: March 25, 2014
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018