Ibuprofen in Migraine Patients

NCT ID: NCT04533568

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

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.

Detailed Description

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Conditions

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Migraine Without Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ibuprofen

400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Group Type EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Dexketoprofen

Intervention Type DRUG

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.

Intervention Type DRUG

Dexketoprofen

50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kecioren Education and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Şeref Kerem Çorbacıoğlu

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kecioren Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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66175679

Identifier Type: -

Identifier Source: org_study_id

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