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

Phase 4

Active, not recruiting

• Conditions: Migraine; Analgesic Affect; Emergency Medicine
• Interventions: Drug: Tenoxicam Injectable Product; Drug: ibuprofen

• Registration Number: NCT06786650
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Primary Completion: 2024-10-15
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2025-01-15
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenoxicam Group. IV Tenoxicam	Tenoxicam Injectable Product	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	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Haydarpasa Numune Training and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey