A Phase 4 interventional study of Dexketoprofen and Normal Saline in Migraine, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-23.
Sponsored by Akdeniz University · Phase 4, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 224 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Drug: Dexketoprofen
50 ml normal saline
Other: Normal Saline
50 mg intravenous arveles in 50 ml saline in 5 minutes
Also known as: Arveles
50 ml normal saline
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.
Time frame: 45 minutes
Adverse Effects
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
Time frame: 45th minutes
| Milestone | Dexketoprofen | Normal Slaline |
|---|---|---|
| Started | 112 | 112 |
| Completed | 112 | 112 |
| Not completed | 0 | 0 |
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.
| units on a scale | Dexketoprofen | Normal Slaline |
|---|---|---|
| Visual Analogue Scale Change | 55 (49 to 60) | 30 (25 to 35) |
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
| participants | Dexketoprofen | Normal Slaline |
|---|---|---|
| Adverse Effects | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexketoprofen | — | 0/112 (0%) | 0/112 (0%) |
| Normal Slaline | — | 0/112 (0%) | 0/112 (0%) |
| Age, Continuous(years) | Dexketoprofen | Normal Slaline | Total |
|---|---|---|---|
| Mean | 36.3 ± 11.1 | 37.6 ± 10.7 | 36.9 ± 11 |
| Sex: Female, Male(Participants) | Dexketoprofen | Normal Slaline | Total |
|---|---|---|---|
| Female | 85 | 83 | 168 |
| Male | 27 | 29 | 56 |
| Region of Enrollment(participants) | Dexketoprofen | Normal Slaline | Total |
|---|---|---|---|
| Turkey | 112 | 112 | 224 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Akdeniz University