Title
IV Dexketoprofen vs Placebo in Migranie Attack
Study of Comparing Dexketoprofen to Placebo in Migraine Attack
Phase
Phase 4Lead Sponsor
Akdeniz UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
MigraineIntervention/Treatment
sodium chloride dexibuprofen ...Study Participants
224H0 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.
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.
50 mg intravenous arveles in 50 ml saline in 5 minutes
50 ml normal saline
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
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
Event Type | Organ System | Event Term |
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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.
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.