IV Dexketoprofen vs Placebo in Migranie Attack

NCT ID: NCT02159547

Last Updated: 2015-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexketoprofen

50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.

Group Type ACTIVE_COMPARATOR

Dexketoprofen

Intervention Type DRUG

50 mg intravenous arveles in 50 ml saline in 5 minutes

normal slaline

50 ml normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

50 ml normal saline

Interventions

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Dexketoprofen

50 mg intravenous arveles in 50 ml saline in 5 minutes

Intervention Type DRUG

Normal Saline

50 ml normal saline

Intervention Type OTHER

Other Intervention Names

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Arveles

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Cenker Eken

Associated Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faruk Gungor, Pyhsician

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Govermental Hospital

Locations

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Antalya Training and Govermental Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Turkcuer I, Serinken M, Eken C, Yilmaz A, Akdag O, 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.

Reference Type BACKGROUND
PMID: 24394884 (View on PubMed)

Other Identifiers

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41/10

Identifier Type: -

Identifier Source: org_study_id

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