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

NCT06786650 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2024-KAEK-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?
2. 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.
3. 3.be administered in 100 cc saline to ensure blinding in the group.
4. 4.Randomisation will be done by closed envelope method.
5. 5.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.
6. 6.Any side effects due to medication will be recorded.

Conditions

Migraine; Analgesic Affect; Emergency Medicine

Keywords

Anti-Inflammatory Agents Non-Steroidal; Acute migrane attack

Outcome Measures

Primary Outcomes (1)

• Achievement of pain palliation

  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.

  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.

Study Arms (2)

Tenoxicam Group. IV Tenoxicam

ACTIVE COMPARATOR

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.

Drug: Tenoxicam Injectable Product

Ibuprofen Group. IV Ibuprofen

SHAM COMPARATOR

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.

Drug: ibuprofen

Interventions

Tenoxicam Injectable Product DRUG

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

Also known as: tenoxicam

Tenoxicam Group. IV Tenoxicam

ibuprofen DRUG

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

Ibuprofen Group. IV Ibuprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 18-65.
• Having a known diagnosis of migraine.
• Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, 34843, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

tenoxicam; Ibuprofen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Colak, Professor Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: January 22, 2025
• Study Start: May 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: June 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 12 months ( 01.01.2025-01.01.2026)
• Access Criteria: The researcher responsible for data analysis will be authorised to access IPD for 1 year.

Locations

TU (1)