Ibuprofen in Migraine Patients

Sponsor

Kecioren Education and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04533568

Collaborator

(none)

160

Enrollment

Location

Arms

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Without Aura	Drug: Ibuprofen 400 mg Drug: Dexketoprofen	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ibuprofen 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.	Drug: Ibuprofen 400 mg 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Experimental: dexketoprofen 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.	Drug: Dexketoprofen 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Arm

Intervention/Treatment

Experimental: ibuprofen

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

Drug: Ibuprofen 400 mg

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

Experimental: dexketoprofen

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

Drug: Dexketoprofen

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

Outcome Measures

Primary Outcome Measures

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

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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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