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

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Metoclopramide 10 mg
* Drug: Placebo
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous metoclopramide<br>Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL) | Drug: Metoclopramide 10 mg<br>* Intravenous form of metoclopramide is in the same appearance with placebo<br>* Other names: Metoclopramide 10 mg (2 mL) in 100 mL normal saline;Drug: Placebo<br>* Intravenous form of metoclopramide is in the same appearance with placebo<br>* Other names: 100 mL normal saline;Drug: Fentanyl<br>* Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute<br>* Other names: Intravenous fentanyl;|
| Placebo Comparator: Placebo<br>0.9% normal saline solution (total 100 mL) | Drug: Metoclopramide 10 mg<br>* Intravenous form of metoclopramide is in the same appearance with placebo<br>* Other names: Metoclopramide 10 mg (2 mL) in 100 mL normal saline;Drug: Placebo<br>* Intravenous form of metoclopramide is in the same appearance with placebo<br>* Other names: 100 mL normal saline;Drug: Fentanyl<br>* Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute<br>* Other names: Intravenous fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between pain scores for both drugs | The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups | 15th and 30th minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting | Change in nausea/vomiting status of the participants | 30th minute | 
| Adverse reactions | Number of participants with adverse events | 30th minute | 
| Need for rescue analgesic | Number of patients needed rescue analgesic at 30th minute | 30th minute | 
| Change in the headache intensity | Change in the headache intensity | Between 24th and 72th hours | 
| Duplicative presentation to the emergency department | With telephone call | Between 24th and 72th hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine disorders, migraine with aura, migraine without aura, pain management, emergency department