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The aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are:
Treatments will;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenoxicam Group. IV Tenoxicam | Active Comparator | Intravenous tenoxicam (20 mg) will be administered in 100 cc saline in 10 minutes to patients admitted to our emergency department with headache due to acute migraine attack. |
|
| Ibuprofen Group. IV Ibuprofen | Sham Comparator | Intravenous ibuprofen (400 mg) will be administered in 100 cc saline in 10 minutes to patients who present to our emergency department due to headache due to acute migraine attack. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenoxicam Injectable Product | Drug | Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of pain palliation | The primary outcome of our study is the achievement of pain palliation. This will be defined as a ≥ 50% reduction in Numerical rating scale (NRS) scores after treatment compared to the baseline score (NRS Baseline). The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Mean and proportional reduction in NRS scores will also be analysed while evaluating the efficacy of the treatment. | NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colak, Professor Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydarpasa Numune Training and Research Hospital | Istanbul | Uskudar | 34843 | Turkey (Türkiye) |
all collected IPD, all IPD that underlie results in a publication
12 months ( 01.01.2025-01.01.2026)
The researcher responsible for data analysis will be authorised to access IPD for 1 year.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 30, 2025 | |
| Reset | Jul 16, 2025 |
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Medical treatments will be administered in 100 cc saline to ensure blindness in both treatment groups. The treatment will be prepared by the responsible investigator and will be numbered with the number on the sealed envelope. Thus, it will be ensured that the administering personnel and the patient will be blinded to the treatment.
|
| ibuprofen | Drug | Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before. |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2025 | Jul 16, 2025 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C032801 | tenoxicam |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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