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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexketoprofen | Active Comparator | 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. |
|
| normal slaline | Placebo Comparator | 50 ml normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexketoprofen | Drug | 50 mg intravenous arveles in 50 ml saline in 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects | The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes. | 45th minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faruk Gungor, Pyhsician | Antalya Training and Govermental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya Training and Govermental Hospital | Antalya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24394884 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Normal Slaline | 50 ml normal saline Normal Saline: 50 ml normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Normal Slaline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | 95% Confidence Interval | units on a scale | 45 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cenker EKEN | Akdeniz University | 00905321593948 | cenkereken@akdeniz.edu.tr |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Other | 50 ml normal saline |
|
50 ml normal saline
Normal Saline: 50 ml normal saline
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Adverse Effects | The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes. | Posted | Number | participants | 45th minutes |
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Normal Slaline | 50 ml normal saline Normal Saline: 50 ml normal saline | 0 | 112 | 0 | 112 |
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| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |