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

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ClinicalTrials.gov Identifier: NCT02314351
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Nurettin Özgür Doğan, Kocaeli University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Metoclopramide 10 mg Drug: Placebo Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Intravenous metoclopramide
Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
Drug: Metoclopramide 10 mg
Intravenous form of metoclopramide is in the same appearance with placebo
Other Name: Metoclopramide 10 mg (2 mL) in 100 mL normal saline

Drug: Placebo
Intravenous form of metoclopramide is in the same appearance with placebo
Other Name: 100 mL normal saline

Drug: Fentanyl
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
Other Name: Intravenous fentanyl

Placebo Comparator: Placebo
0.9% normal saline solution (total 100 mL)
Drug: Metoclopramide 10 mg
Intravenous form of metoclopramide is in the same appearance with placebo
Other Name: Metoclopramide 10 mg (2 mL) in 100 mL normal saline

Drug: Placebo
Intravenous form of metoclopramide is in the same appearance with placebo
Other Name: 100 mL normal saline

Drug: Fentanyl
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
Other Name: Intravenous fentanyl




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314351


Locations
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Turkey
Kocaeli University, Faculty of Medicine
Kocaeli, Turkey, 41000
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Nurettin Özgür Doğan, Assoc. Prof Kocaeli University, Faculty of Medicine

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Responsible Party: Nurettin Özgür Doğan, M.D., Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT02314351     History of Changes
Other Study ID Numbers: KOU KAEK 2014/315
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Nurettin Özgür Doğan, Kocaeli University:
migraine disorders
migraine with aura
migraine without aura
pain management
emergency department

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fentanyl
Metoclopramide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action