IV Dexketoprofen vs Placebo in Migranie Attack

Phase 4

Completed

• Conditions: Migraine
• Interventions: Other: Normal Saline; Drug: Dexketoprofen

• Registration Number: NCT02159547
• Lead Sponsor: Akdeniz University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-03-16
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-27
• Last Update Submitted: 2015-06-27
• Results First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal slaline	Normal Saline	50 ml normal saline
Dexketoprofen	Dexketoprofen	50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Change	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 Outcome Measures

Name	Time	Method
Adverse Effects	45th minutes	The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.

Trial Locations

Locations (1)

Antalya Training and Govermental Hospital; 🇹🇷 Antalya, Turkey