Dexamethasone for Migraine - Dose Comparison
Study Details
Study Description
Brief Summary
Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine.
All patients will also be treated with metoclopramide.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Investigational medications. Medications in each study arm are as follows:
- Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV
- Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 16 mg IV Assignment. Will be concealed. The research pharmacist will determine assignment based on a random number sequence. Randomization. Randomization will occur in blocks of 4 based on a random number generator. Blinding. Patients, clinicians, and research personnel will be blinded. Stratification. Subjects will be stratified by study site (Moses or Weiler) and baseline pain intensity (moderate or severe).
Follow-up phone calls will be performed 48 hours and 7 days after ED discharge. At the first call, the next follow-up phone call will be scheduled. Attempts to complete the follow-up calls successfully will be made every eight hours until deemed futile. At this point, questionnaires will be sent by express courier, and failing this, the investigator will perform a home visit.
At the 48-hour phone call, the focus will be assessments of pain, functional status, migraine associated features, adverse events, satisfaction with the medication received, and use of rescue medication. The focus of the seven day phone call will be on the total number of days with headache since ED discharge, the need for repeat ED visits, healthcare providers visited, days of work missed, and adverse medication effects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexamethasone 4mg Dexamethasone 4mg, administered intravenously |
Drug: Dexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Other Names:
|
| Active Comparator: Dexamethasone 16mg Dexamethasone 16mg, administered intravenously |
Drug: Dexamethasone 16mg
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with headaches who have sustained headache relief for 48 hours [48 hours]
The primary outcome for this study will be sustained headache relief for 48 hours: achieving a headache intensity = "none" or "mild" within two hours of medication administration and maintaining this level, without requiring additional headache medication, for the entire 48 follow-up period
Secondary Outcome Measures
- Number of subjects with headache who have relief within two hours of medication administration [Two hours]
achieving a headache level = mild or none within two hours of medication administration without requiring rescue medication
- Number of days with headache [One week]
Number of headache days during the week after ED discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
- Moderate or severe migraine
Exclusion Criteria:
-
Medication contra-indication
-
Concern for 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
- Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-10562