Clinical trial NCT04533568: Ibuprofen in Migraine Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Without Aura
Keywords: migraine without migraine
intravenous ibuprofen
intravenous dexketoprofen
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Resolving of Headache at 60 minute
timeFrame: 60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes
Secondary outcomes:
measure: Resolving of Headache at 30 minute
timeFrame: 30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes
measure: Needing of rescue treatment
timeFrame: 60 minutes after treatment
measure: Side and adverse effects
timeFrame: From start of performing drug to in the first 24 hours after drug administration
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Training and Research Hospital
Study officials:
References: