Skip to main content
OpenTrials
Completed

NCT Number: NCT04252521

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adiyaman University Research Hospital

Adıyaman, Central, 02000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide

Drug

10 mg Metpamid in 100 ml normal saline solution

Other names: Metpamid (metoclopramide)

dexketoprofen trometamol

Drug

50 mg dexketoprofen trometamol in 100 ml normal saline solution

Other names: Metadem (dexketoprofen trometamol)

metoclopramide+dexketoprofen trometamol

Drug

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

Other names: Metpamid+Metadem

Primary outcomes

  1. Change of the intensity of pain

    Time frame: 15 minutes and 30 minutes after the study drug administered

    Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later after the study drug administered

Secondary outcomes

  1. Adverse events

    Time frame: 30 minutes after

    30 minutes after the study drug administered

  2. need to rescue medication

    Time frame: 30 minutes after

    30 minutes after the study drug administered

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.