Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
209 participants
INTERVENTIONAL
2019-12-22
2022-12-31
Brief Summary
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All patients will also be treated with metoclopramide.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone 4mg
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Dexamethasone 16mg
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Interventions
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Dexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Dexamethasone 16mg
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concern for secondary cause of headache
18 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-10562
Identifier Type: -
Identifier Source: org_study_id
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