IV Dexketoprofen vs Placebo in Migranie Attack

Migraine Clinical Trial

Official title:

Study of Comparing Dexketoprofen to Placebo in Migraine Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159547
• Other study ID #: 41/10
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2014
• Last updated: June 27, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Dexketoprofen
50 mg intravenous arveles in 50 ml saline in 5 minutes

Other:
• Normal Saline
50 ml normal saline

Locations

Country	Name	City	State
Turkey	Antalya Training and Govermental Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Turkcuer I, Serinken M, Eken C, Yilmaz A, Akdag Ö, Uyan E, Kiray C, Elicabuk H. Intravenous paracetamol versus dexketoprofen in acute migraine attack in the emergency department: a randomised clinical trial. Emerg Med J. 2014 Mar;31(3):182-5. doi: 10.1136/emermed-2013-203044. Epub 2014 Jan 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Change	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.	45 minutes	No
Secondary	Adverse Effects	The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.	45th minutes	Yes