Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
NCT ID: NCT06786650
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-05-15
2025-06-30
Brief Summary
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1. Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?
2. Is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? Researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack.
Treatments will;
1. be administered in 100 cc saline to ensure blinding in the group.
2. Randomisation will be done by closed envelope method.
3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the drugs. NRS scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment.
4. Any side effects due to medication will be recorded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tenoxicam Group. IV Tenoxicam
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.
Tenoxicam Injectable Product
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
Ibuprofen Group. IV Ibuprofen
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.
ibuprofen
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
Interventions
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Tenoxicam Injectable Product
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
ibuprofen
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having a known diagnosis of migraine.
* Exclusion of secondary causes to explain the headache in the emergency department.
* Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.
Exclusion Criteria
* Being pregnant or breastfeeding.
* Being admitted to the emergency department with headache due to causes other than migraine (secondary).
* Being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission.
* Having a history of allergy to any of the drugs to be used in the study.
* Having a history of comorbidities for which the drugs to be used in the study are contraindicated.
18 Years
65 Years
ALL
No
Sponsors
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Haydarpasa Numune Training and Research Hospital
OTHER
Responsible Party
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Sinem Dogruyol
Associate Professor Doctor
Principal Investigators
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Colak, Professor Dr
Role: PRINCIPAL_INVESTIGATOR
Locations
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Haydarpasa Numune Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Countries
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Other Identifiers
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2024-KAEK-18
Identifier Type: -
Identifier Source: org_study_id
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