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Completed

NCT Number: NCT04533568

Ibuprofen in Migraine Patients

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.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kecioren Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 400 mg

Drug

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

Dexketoprofen

Drug

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

Primary outcomes

  1. Resolving of Headache at 60 minute

    Time frame: 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 outcomes

  1. Resolving of Headache at 30 minute

    Time frame: 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.

  2. Needing of rescue treatment

    Time frame: 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).

  3. Side and adverse effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kecioren Education and Training Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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