Ibuprofen in Migraine Patients

K

Kecioren Education and Training Hospital

Status and phase

Completed
Phase 4

Conditions

Migraine Without Aura

Treatments

Drug: Dexketoprofen
Drug: Ibuprofen 400 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04533568
66175679

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

160 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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