Ibuprofen in Migraine Patients

Phase 4

Completed

• Conditions: Migraine Without Aura
• Interventions: Drug: Dexketoprofen; Drug: Ibuprofen 400 mg

• Registration Number: NCT04533568
• Lead Sponsor: Kecioren Education and Training Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-08-31
• Study Start: 2020-09-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-12
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexketoprofen	Dexketoprofen	50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
ibuprofen	Ibuprofen 400 mg	400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Primary Outcome Measures

Name	Time	Method
Resolving of Headache at 60 minute	60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes	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.

Secondary Outcome Measures

Name	Time	Method
Side and adverse effects	From start of performing drug to in the first 24 hours after drug administration	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
Resolving of Headache at 30 minute	30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes	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.
Needing of rescue treatment	60 minutes after 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).

Trial Locations

Locations (1)

Kecioren Training and Research Hospital; 🇹🇷 Ankara, Turkey