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

Haydarpasa Numune Training and Research Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Analgesic Affect; Emergency Medicine; Migraine

Treatments: Drug: Tenoxicam Injectable Product; Drug: ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT06786650

2024-KAEK-18

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Tenoxicam Group. IV Tenoxicam

Active Comparator group

Description:

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.

Treatment:

Drug: Tenoxicam Injectable Product

Ibuprofen Group. IV Ibuprofen

Sham Comparator group

Description:

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.

Treatment:

Drug: ibuprofen