Back to resultsIV Dexketoprofen vs Placebo in Migranie Attack
Primary Purpose
Migraine
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexketoprofen
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, emergency department, dexketoprofen, placebo
Eligibility 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
Sites / Locations
- Antalya Training and Govermental Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexketoprofen
normal slaline
Arm Description
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
50 ml normal saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse Effects
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02159547
Brief Title
IV Dexketoprofen vs Placebo in Migranie Attack
Official Title
Study of Comparing Dexketoprofen to Placebo in Migraine Attack
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, emergency department, dexketoprofen, placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexketoprofen
Arm Type
Active Comparator
Arm Description
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Arm Title
normal slaline
Arm Type
Placebo Comparator
Arm Description
50 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
Arveles
Intervention Description
50 mg intravenous arveles in 50 ml saline in 5 minutes
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
50 ml normal saline
Primary Outcome Measure Information:
Title
Visual Analogue Scale Change
Description
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.
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Adverse Effects
Description
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
Time Frame
45th minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faruk Gungor, Pyhsician
Organizational Affiliation
Antalya Training and Govermental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Govermental Hospital
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
24394884
Citation
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.
Results Reference
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Learn more about this trial
IV Dexketoprofen vs Placebo in Migranie Attack
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