Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack

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.

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Key information

Conditions

Migraine Analgesic Affect Brain Diseases Central Nervous System Diseases Emergency Medicine Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, 34843, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenoxicam Injectable Product

Drug

Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.

Other names: tenoxicam

Ibuprofen

Drug

Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.

Primary outcomes

Achievement of pain palliation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jan 22, 2025
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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