Dexamethasone for Migraine - Dose Comparison
- Registration Number
- NCT04112823
- Lead Sponsor
- Montefiore Medical Center
- 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.
- Detailed Description
Investigational medications. Medications in each study arm are as follows:
A. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV B. 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 (emergency department) 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- Moderate or severe migraine
- Medication contra-indication
- Concern for secondary cause of headache
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone 16mg Dexamethasone 16mg Dexamethasone 16mg, administered intravenously Dexamethasone 4mg Dexamethasone 4mg Dexamethasone 4mg, administered intravenously
- Primary Outcome Measures
Name Time Method Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours 48 hours The number of subjects achieving sustained headache relief for 48 hours and maintaining this level, without requiring additional rescue therapy for the entire 48 hour follow up period, will be determined. Headache relief will be defined as the number of subjects reporting a headache intensity of either "none" or "mild."
- Secondary Outcome Measures
Name Time Method Patient Preference for Receiving the Same Medication for a Subsequent Headache 48 hours During the 48 hour follow up patients were queried as to whether they would want the same headache treatment regimen during the onset of a subsequent headache. The number of responses were tabulated and reported.
Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration Two hours The number of subjects who achieve a headache intensity level of either "none" or "mild" within two hours of medication administration, without requiring rescue medication, will be determined.
Additional Headache Medication in the ED Up to 24 hours The number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined.
Use of Additional Headache Medication After ED Discharge Up to 24 hours The number of participants requiring the use of additional headache medication following ED discharge will be summarized.
Number of Days With Headache One week The median number of headache days during the week after ED discharge will be determined.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States