Title

IV Dexketoprofen vs Placebo in Migranie Attack
Study of Comparing Dexketoprofen to Placebo in Migraine Attack
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    224
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.
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 Started
May 31
2014
Primary Completion
Aug 31
2014
Study Completion
Aug 31
2014
Results Posted
Jul 23
2015
Estimate
Last Update
Jul 23
2015
Estimate

Drug Dexketoprofen

50 mg intravenous arveles in 50 ml saline in 5 minutes

  • Other names: Arveles

Other Normal Saline

50 ml normal saline

Dexketoprofen Active Comparator

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

normal slaline Placebo Comparator

50 ml normal saline

Criteria

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

Summary

Dexketoprofen

Normal Slaline

All Events

Event Type Organ System Event Term

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.

Dexketoprofen

55.0
units on a scale (Median)
95% Confidence Interval: 49.0 to 60.0

Normal Slaline

30.0
units on a scale (Median)
95% Confidence Interval: 25.0 to 35.0

Adverse Effects

The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.

Dexketoprofen

Normal Slaline

Total

224
Participants

Age, Continuous

36.9
years (Mean)
Standard Deviation: 11

Region of Enrollment

Sex: Female, Male

Overall Study

Dexketoprofen

Normal Slaline