Status:
UNKNOWN
The Effect of Intravenous Fluid Therapy in Acute Migraine Attacks
Lead Sponsor:
Marmara University
Conditions:
Migraine Disorders
Headache
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a single-center, double-blind, randomized protocol comparison. The study will be conducted in Marmara University School of Medicine Pendik Training and Research Hospital, Department of Em...
Detailed Description
Introduction Headache is a common complaint that is seen in 70-80% of the population and is a common health problem in emergency services. When evaluating the patient with headache, the first step is ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age 18 years or older
- migraine with or without aura according to International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria confirmed by one-to-one physical exam in the ED
- no declaration and sign of pregnancy, or pregnancy not diagnosed during the ED evaluation before randomization,
- did not receive any IV fluid of 100 cc or more at any facility in the last 12 hours,
- intramuscular diclofenac potassium 75 mg, the standard treatment protocol, is ordered by the physician (no history of known allergic reaction to diclofenac potassium),
- severe dehydration not present as determined by the researcher (hypotension, dry mouth, tongue and eyeballs, decreased urine output)
- no other indication for fluid infusion,
- no contraindication to fluid administration (heart failure patients with diuretic use, renal failure patients with fluid restriction, hemodynamic instability),
- do not have accompanying symptoms and signs related to headaches secondary to other obvious pathologies rather than migraine,
- consent to be included in the study.
- Exclusion criteria: no patients will be excluded from the study after randomization. All patients will be evaluated for the primary outcome with an intent-to-treat approach.
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04287140
Start Date
April 1 2020
End Date
November 1 2021
Last Update
December 29 2020
Active Locations (1)
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1
Marmara University Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye)