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Completed

NCT Number: NCT02314351

Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.

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Key information

Conditions

Migraine Disorders Agnosia Brain Diseases Central Nervous System Diseases Disease Attributes Emergencies Headache Disorders Headache Disorders, Primary Migraine with Aura Migraine without Aura Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kocaeli University, Faculty of Medicine

Köseköy, Kocaeli, 41000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
  • The patients older than 18 years
  • Patients who agree to participate to the study by reading and signing the informed consent document

Exclusion criteria

  • The patients younger than 18 years
  • Pregnants
  • Patients taking any analgesic drugs last 2 hours
  • Documented or declared allergy to metoclopramide
  • Patients who are hemodynamically unstable
  • Patients who do not agree to participate to the study

Treatment and study plan

metoclopramide 10 mg

Drug

Intravenous form of metoclopramide is in the same appearance with placebo

Other names: Metoclopramide 10 mg (2 mL) in 100 mL normal saline

Placebo

Drug

Intravenous form of metoclopramide is in the same appearance with placebo

Other names: 100 mL normal saline

Fentanyl

Drug

Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Other names: Intravenous fentanyl

Primary outcomes

  1. The difference between pain scores for both drugs

    Time frame: 15th and 30th minutes

    The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups

Secondary outcomes

  1. Nausea and vomiting

    Time frame: 30th minute

    Change in nausea/vomiting status of the participants

  2. Adverse reactions

    Time frame: 30th minute

    Number of participants with adverse events

  3. Need for rescue analgesic

    Time frame: 30th minute

    Number of patients needed rescue analgesic at 30th minute

  4. Change in the headache intensity

    Time frame: Between 24th and 72th hours

    Change in the headache intensity

  5. Duplicative presentation to the emergency department

    Time frame: Between 24th and 72th hours

    With telephone call

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2014
Registry last updated
Jan 4, 2017

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.

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