Analgesic Affect, Emergency Medicine, Migraine
Conditions
Keywords
Anti-Inflammatory Agents Non-Steroidal, Acute migrane attack
Brief summary
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: 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.
Interventions
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
DRUGibuprofen
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
Sponsors
Haydarpasa Numune Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Being between the ages of 18-65. * 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 under 18 years of age. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of pain palliation | 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. | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed