Dexamethasone for Migraine - Dose Comparison

  • STATUS
    Recruiting
  • End date
    Jul 27, 2022
  • participants needed
    360
  • sponsor
    Montefiore Medical Center
Updated on 31 August 2021
metoclopramide
acute migraine

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.

Description

Investigational medications. Medications in each study arm are as follows:

  1. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV
  2. 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.

Details
Condition Primary Stabbing Headache, Migraine and Cluster Headaches, migraines, Migraine, Migraine (Adult), Migraine (Pediatric)
Treatment Dexamethasone 4mg, Dexamethasone 16mg
Clinical Study IdentifierNCT04112823
SponsorMontefiore Medical Center
Last Modified on31 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Moderate or severe migraine

Exclusion Criteria

Medication contra-indication
Concern for secondary cause of headache
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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