Corticosteroids for Acute Migraine in the Emergency Department
Study Details
Study Description
Brief Summary
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Control Metoclopramide 10mg IV+ dexamethasone 10mg IM |
Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Drug: Dexamethasone
dexamethasone 10mg intramuscular injection
|
Active Comparator: Experimental Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM |
Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Drug: methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Headache Days as Self-reported by Participants [7 days after discharge from emergency department]
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
Secondary Outcome Measures
- Number of Participants With Sustained Headache Freedom [7 days after discharge from emergency department]
Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.
- Medication Preference as Assessed by Self-report [7 days after discharge from emergency department]
Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes".
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Migraine without aura criteria (International Classification of Headache Disorders 3B )
-
Headache rated as moderate or severe in intensity
Exclusion Criteria:
-
Concern for secondary cause of headache
-
Contra-indications to investigational medications
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Montefiore Medical Center--Einstein | Bronx | New York | United States | 10461 |
2 | Montefiore Medical Center-Moses | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.- 2016-6342
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Control | Experimental |
---|---|---|
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection |
Period Title: Overall Study | ||
STARTED | 109 | 111 |
COMPLETED | 101 | 106 |
NOT COMPLETED | 8 | 5 |
Baseline Characteristics
Arm/Group Title | Control | Experimental | Total |
---|---|---|---|
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection | Total of all reporting groups |
Overall Participants | 109 | 111 | 220 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
36
(13)
|
39
(16)
|
38
(15)
|
Sex: Female, Male (Count of Participants) | |||
Female |
93
85.3%
|
94
84.7%
|
187
85%
|
Male |
16
14.7%
|
17
15.3%
|
33
15%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (Count of Participants) | |||
United States |
109
100%
|
111
100%
|
220
100%
|
Duration of headache (hours) [Median (Inter-Quartile Range) ] | |||
Median (Inter-Quartile Range) [hours] |
48
|
72
|
72
|
Outcome Measures
Title | Headache Days as Self-reported by Participants |
---|---|
Description | At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. |
Time Frame | 7 days after discharge from emergency department |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control | Experimental |
---|---|---|
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection |
Measure Participants | 101 | 106 |
Mean (95% Confidence Interval) [days] |
3.0
|
3.3
|
Title | Number of Participants With Sustained Headache Freedom |
---|---|
Description | Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. |
Time Frame | 7 days after discharge from emergency department |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control | Experimental |
---|---|---|
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection |
Measure Participants | 107 | 110 |
Count of Participants [Participants] |
10
9.2%
|
6
5.4%
|
Title | Medication Preference as Assessed by Self-report |
---|---|
Description | Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes". |
Time Frame | 7 days after discharge from emergency department |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control | Experimental |
---|---|---|
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection |
Measure Participants | 101 | 106 |
Count of Participants [Participants] |
76
69.7%
|
75
67.6%
|
Adverse Events
Time Frame | 1 week | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Control | Experimental | ||
Arm/Group Description | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection | ||
All Cause Mortality |
||||
Control | Experimental | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/111 (0%) | ||
Serious Adverse Events |
||||
Control | Experimental | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/111 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Control | Experimental | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/109 (2.8%) | 16/111 (14.4%) | ||
Nervous system disorders | ||||
Akathisia | 2/109 (1.8%) | 2 | 7/111 (6.3%) | 7 |
Skin and subcutaneous tissue disorders | ||||
Injection site reaction | 1/109 (0.9%) | 1 | 9/111 (8.1%) | 9 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Benjamin W. Friedman, MD |
---|---|
Organization | Montefiore Health |
Phone | 17189206626 |
befriedm@montefiore.org |
- 2016-6342