Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine
Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine
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.
Study objective: The objective of this study is to determine the analgesic efficacy and
 safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus
 metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to
 the emergency department (ED).

 Methods of Measurements:

 This single-center, randomized, double-blind study will be conducted in a tertiary care ED.
 Eligible patients who met the migraine criteria of the International Headache Society will be
 randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen
 trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.

 Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no
 pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30
 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th
 minutes of treatment. The secondary outcome measures are the presence of adverse effects and
 the requirement of rescue medicine.

 Primary Data Analysis:

 The study was planned as a superiority trial. The difference in the VAS values between the
 groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and
 thus the minimum required the number of patients for each group was calculated as 27 at the
 alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to
 the intention to treat analysis. Differences between time intervals within groups and between
 groups and statistical significance were expressed by 95% confidence intervals (95% CI).
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