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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2020-01-03

Brief Summary

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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.

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Detailed Description

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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

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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metoclopramide+ dexketoprofen trometamol

10 mg metoclopramide+ 50 mg dexketoprofen trometamol

Group Type ACTIVE_COMPARATOR

metoclopramide+dexketoprofen trometamol

Intervention Type DRUG

10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution

metoclopramide

10 mg metoclopramide

Group Type EXPERIMENTAL

metoclopramide

Intervention Type DRUG

10 mg Metpamid in 100 ml normal saline solution

dexketoprofen trometamol

50 mg dexketoprofen trometamol

Group Type EXPERIMENTAL

dexketoprofen trometamol

Intervention Type DRUG

50 mg dexketoprofen trometamol in 100 ml normal saline solution

Interventions

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metoclopramide

10 mg Metpamid in 100 ml normal saline solution

Intervention Type DRUG

dexketoprofen trometamol

50 mg dexketoprofen trometamol in 100 ml normal saline solution

Intervention Type DRUG

metoclopramide+dexketoprofen trometamol

10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution

Intervention Type DRUG

Other Intervention Names

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Metpamid (metoclopramide) Metadem (dexketoprofen trometamol) Metpamid+Metadem

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No