Migraine
Conditions
Keywords
migraine, emergency department, dexketoprofen, placebo
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.
Interventions
DRUGDexketoprofen
50 mg intravenous arveles in 50 ml saline in 5 minutes
OTHERNormal Saline
50 ml normal saline
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Change | 45 minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects | 45th minutes | The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexketoprofen 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes | 112 |
| Normal Slaline 50 ml normal saline
Normal Saline: 50 ml normal saline | 112 |
| Total | 224 |
Baseline characteristics
| Characteristic | Dexketoprofen | Normal Slaline | Total |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 11.1 | 37.6 years STANDARD_DEVIATION 10.7 | 36.9 years STANDARD_DEVIATION 11 |
| Region of Enrollment Turkey | 112 participants | 112 participants | 224 participants |
| Sex: Female, Male Female | 85 Participants | 83 Participants | 168 Participants |
| Sex: Female, Male Male | 27 Participants | 29 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 112 |
| serious Total, serious adverse events | 0 / 112 | 0 / 112 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexketoprofen | Visual Analogue Scale Change | 55 units on a scale |
| Normal Slaline | Visual Analogue Scale Change | 30 units on a scale |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexketoprofen | Adverse Effects | 0 participants |
| Normal Slaline | Adverse Effects | 0 participants |