Study Results
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Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2020-09-01
2021-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ibuprofen
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Ibuprofen 400 mg
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
dexketoprofen
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Dexketoprofen
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Interventions
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Ibuprofen 400 mg
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Dexketoprofen
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Kecioren Education and Training Hospital
OTHER
Responsible Party
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Şeref Kerem Çorbacıoğlu
Associated Professor
Locations
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Kecioren Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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66175679
Identifier Type: -
Identifier Source: org_study_id
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