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

NCT ID: NCT06786650

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Migraine Analgesic Affect Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tenoxicam Injectable Product

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

ibuprofen

Intervention Type DRUG

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

Interventions

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Tenoxicam Injectable Product

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

Intervention Type DRUG

ibuprofen

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

Intervention Type DRUG

Other Intervention Names

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tenoxicam

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sinem Dogruyol

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colak, Professor Dr

Role: PRINCIPAL_INVESTIGATOR

Locations

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Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024-KAEK-18

Identifier Type: -

Identifier Source: org_study_id

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