IV Dexketoprofen vs Placebo in Migranie Attack

Akdeniz University

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Other: Normal Saline; Drug: Dexketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02159547

41/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

Dexketoprofen

Active Comparator group

Description:

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

Treatment:

Drug: Dexketoprofen

normal slaline

Placebo Comparator group

Description:

50 ml normal saline

Treatment:

Other: Normal Saline