Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine

Study Overview
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Brief Summary
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Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.

Detailed Description
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Study objective: The objective of this study is to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED). Methods of Measurements: This single-center, randomized, double-blind study will be conducted in a tertiary care ED. Eligible patients who met the migraine criteria of the International Headache Society will be randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide. Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures are the presence of adverse effects and the requirement of rescue medicine. Primary Data Analysis: The study was planned as a superiority trial. The difference in the VAS values between the groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and thus the minimum required the number of patients for each group was calculated as 27 at the alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to the intention to treat analysis. Differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).

Official Title
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Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Acute Migraine Attack in the Emergency Department: a Randomized Double-blind Controlled Trial

Conditions
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Migraine

Intervention / Treatment
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* Drug: metoclopramide
* Drug: dexketoprofen trometamol
* Drug: metoclopramide+dexketoprofen trometamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine Exclusion Criteria: Patients who refused to participate in the study Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metoclopramide+ dexketoprofen trometamol<br>10 mg metoclopramide+ 50 mg dexketoprofen trometamol | Drug: metoclopramide+dexketoprofen trometamol<br>* 10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution<br>* Other names: Metpamid+Metadem;|
| Experimental: metoclopramide<br>10 mg metoclopramide | Drug: metoclopramide<br>* 10 mg Metpamid in 100 ml normal saline solution<br>* Other names: Metpamid (metoclopramide);|
| Experimental: dexketoprofen trometamol<br>50 mg dexketoprofen trometamol | Drug: dexketoprofen trometamol<br>* 50 mg dexketoprofen trometamol in 100 ml normal saline solution<br>* Other names: Metadem (dexketoprofen trometamol);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the intensity of pain | Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later after the study drug administered | 15 minutes and 30 minutes after the study drug administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 30 minutes after the study drug administered | 30 minutes after | 
| need to rescue medication | 30 minutes after the study drug administered | 30 minutes after |