Ibuprofen in Migraine Patients

Study Overview
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Brief Summary
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In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura. In this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl. Patients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score.

Official Title
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A Randomized-controlled Study; Comparison of the Effectiveness of Intravenous Ibuprofen and Intravenous Dexketoprofen in the Treatment of Migraine-related Headache in the Emergency Department

Conditions
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Migraine Without Aura

Intervention / Treatment
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* Drug: Ibuprofen 400 mg
* Drug: Dexketoprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition Patients whose pre-treatment VAS scores are more than 40 point. Patients who give written and verbal consent to include study. Exclusion Criteria: Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours Patients had a history of allergy to any of the drugs used in this study Patients used any anticoagulant-agents, Patients had bleeding diathesis patients were pregnant, patients were breastfeeding mothers Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease Patients had peptic ulcer Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: ibuprofen<br>400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes. | Drug: Ibuprofen 400 mg<br>* 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.<br>|
| Experimental: dexketoprofen<br>50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes. | Drug: Dexketoprofen<br>* 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolving of Headache at 60 minute | Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments. | 60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolving of Headache at 30 minute | Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 30th minutes after treatments. | 30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes | 
| Needing of rescue treatment | 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache pain score - which measured by using Visual Analog Scale (VAS) - does not decrease by more than 50% from pretreatment-VAS score. This scale ranged from 0mm (no pain) to 100mm (worst pain). | 60 minutes after treatment | 
| Side and adverse effects | any side/adverse effects related to study drugs such as hypotension, bradycardia, or anaphylaxis or local adverse effects such as pain or hematoma in the injection area | From start of performing drug to in the first 24 hours after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine without migraine, intravenous ibuprofen, intravenous dexketoprofen