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

June 21, 2025 updated by: Sinem Dogruyol, Haydarpasa Numune Training and Research Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Uskudar
      • Istanbul, Uskudar, Turkey, 34843
        • Haydarpasa Numune Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenoxicam Group. IV Tenoxicam
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
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
Other Names:
  • tenoxicam
Sham Comparator: Ibuprofen Group. IV 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.
Drug: ibuprofen
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haydarpasa Numune Training and Research Hospital

Investigators

  • Principal Investigator: Colak, Professor Dr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KAEK-18 (Other Identifier: İSTANBUL HAYDARPAŞA NUMUNE EĞİTİM VE ARAŞTIRMA HASTANESİ KLİNİK ARAŞTIRMALAR ETİK KURULU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

12 months ( 01.01.2025-01.01.2026)

IPD Sharing Access Criteria

The researcher responsible for data analysis will be authorised to access IPD for 1 year.

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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