NCT04252521

Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Adiyaman University Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	metoclopramide	10 mg Metpamid in 100 ml normal saline solution
DRUG	dexketoprofen trometamol	50 mg dexketoprofen trometamol in 100 ml normal saline solution
DRUG	metoclopramide+dexketoprofen trometamol	10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution

Timeline

• Start date: 2019-07-03
• Primary completion: 2020-01-03
• Completion: 2020-01-03
• First posted: 2020-02-05
• Last updated: 2024-02-08

Locations

1 site across 1 country: Turkey (Türkiye)