Clinical trial

Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Acute Migraine Attack in the Emergency Department: a Randomized Double-blind Controlled Trial

Name
66175679-514.04.01
Description
Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.
Trial arms
Trial start
2019-07-03
Estimated PCD
2020-01-03
Trial end
2020-01-03
Status
Completed
Treatment
metoclopramide
10 mg Metpamid in 100 ml normal saline solution
Arms:
metoclopramide
Other names:
Metpamid (metoclopramide)
dexketoprofen trometamol
50 mg dexketoprofen trometamol in 100 ml normal saline solution
Arms:
dexketoprofen trometamol
Other names:
Metadem (dexketoprofen trometamol)
metoclopramide+dexketoprofen trometamol
10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution
Arms:
metoclopramide+ dexketoprofen trometamol
Other names:
Metpamid+Metadem
Size
150
Primary endpoint
Change of the intensity of pain
15 minutes and 30 minutes after the study drug administered
Eligibility criteria
Inclusion Criteria: -Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine Exclusion Criteria: * Patients who refused to participate in the study * Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2024-02-08

1 organization

3 products

1 indication

Indication
Migraine