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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous metoclopramide | Active Comparator | Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL) |
|
| Placebo | Placebo Comparator | 0.9% normal saline solution (total 100 mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide 10 mg | Drug | Intravenous form of metoclopramide is in the same appearance with placebo |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurettin Özgür Doğan, Assoc. Prof | Kocaeli University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University, Faculty of Medicine | Köseköy | Kocaeli | 41000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D000377 | Agnosia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D000077330 | Saline Solution |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Placebo | Drug | Intravenous form of metoclopramide is in the same appearance with placebo |
|
|
| Fentanyl | Drug | Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute |
|
|
| 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 |
| D009422 | Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |