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This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:
Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.
The main objective is the evaluation of healing times from pain in the 3 groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose |
|
| 2 | Active Comparator | metoclopramide 0,15 mg/Kg + placebo per os |
|
| 3 | Active Comparator | ketoprofen 1 mg/Kg and placebo in single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoclopramide | Drug | metoclopramide 0,15 mg/kg |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of healing times from pain in the 3 groups | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial | 2 and 24 hours respectively | |
| need of a rescue drug for lack of effect in every arms of the trial | 2 hours and 24 hours for relapses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo Guglia, MD | IRCCS Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edoardo Guglia | Trieste | 34100 | Italy |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| 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 |
| D007660 | Ketoprofen |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Drug |
placebo per os |
|
| ketoprofen | Drug | ketoprofen 1 mg/Kg |
|
| D009422 | Nervous System Diseases |
| 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 |
| D010666 | Phenylpropionates |