Ibuprofen in Migraine Patients

Migraine Without Aura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533568
• Other study ID #: 66175679
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Kecioren Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolving of Headache at 60 minute	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.	60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes
Secondary	Resolving of Headache at 30 minute	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.	30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes
Secondary	Needing of rescue 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).	60 minutes after treatment
Secondary	Side and adverse effects	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	From start of performing drug to in the first 24 hours after drug administration