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OpenTrials
Completed

NCT Number: NCT02159547

IV Dexketoprofen vs Placebo in Migranie Attack

H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department.

H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Disease Attributes Emergencies Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antalya Training and Govermental Hospital

Antalya, Turkey (Türkiye)

About this study

Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients presented with headache who diagnosed as migraine attack according to the international headache society

Exclusion criteria

  • denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy

Treatment and study plan

Dexketoprofen

Drug

50 mg intravenous arveles in 50 ml saline in 5 minutes

Other names: Arveles

Normal Saline

Other

50 ml normal saline

Primary outcomes

  1. Visual Analogue Scale Change

    Time frame: 45 minutes

    Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.

Secondary outcomes

  1. Adverse Effects

    Time frame: 45th minutes

    The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Study of Comparing Dexketoprofen to Placebo in Migraine Attack

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2014
Registry last updated
Jul 23, 2015

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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