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Ibuprofen in Migraine Patients

Primary Purpose

Migraine Without Aura

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ibuprofen 400 mg
Dexketoprofen
Sponsored by
Kecioren Education and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Without Aura focused on measuring migraine without migraine, intravenous ibuprofen, intravenous dexketoprofen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition
  • Patients whose pre-treatment VAS scores are more than 40 point.
  • Patients who give written and verbal consent to include study.

Exclusion Criteria:

  • Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours
  • Patients had a history of allergy to any of the drugs used in this study
  • Patients used any anticoagulant-agents,
  • Patients had bleeding diathesis
  • patients were pregnant,
  • patients were breastfeeding mothers
  • Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease
  • Patients had peptic ulcer
  • Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl

Sites / Locations

  • Kecioren Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ibuprofen

dexketoprofen

Arm Description

400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Outcomes

Primary Outcome Measures

Resolving of Headache at 60 minute
Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments.

Secondary Outcome Measures

Resolving of Headache at 30 minute
Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 30th minutes after treatments.
Needing of rescue treatment
60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache pain score - which measured by using Visual Analog Scale (VAS) - does not decrease by more than 50% from pretreatment-VAS score. This scale ranged from 0mm (no pain) to 100mm (worst pain).
Side and adverse effects
any side/adverse effects related to study drugs such as hypotension, bradycardia, or anaphylaxis or local adverse effects such as pain or hematoma in the injection area

Full Information

First Posted
August 22, 2020
Last Updated
December 12, 2021
Sponsor
Kecioren Education and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04533568
Brief Title
Ibuprofen in Migraine Patients
Official Title
A Randomized-controlled Study; Comparison of the Effectiveness of Intravenous Ibuprofen and Intravenous Dexketoprofen in the Treatment of Migraine-related Headache in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura. In this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl. Patients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
Keywords
migraine without migraine, intravenous ibuprofen, intravenous dexketoprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen
Arm Type
Experimental
Arm Description
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Arm Title
dexketoprofen
Arm Type
Experimental
Arm Description
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Intervention Description
50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
Primary Outcome Measure Information:
Title
Resolving of Headache at 60 minute
Description
Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments.
Time Frame
60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes
Secondary Outcome Measure Information:
Title
Resolving of Headache at 30 minute
Description
Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 30th minutes after treatments.
Time Frame
30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes
Title
Needing of rescue treatment
Description
60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache pain score - which measured by using Visual Analog Scale (VAS) - does not decrease by more than 50% from pretreatment-VAS score. This scale ranged from 0mm (no pain) to 100mm (worst pain).
Time Frame
60 minutes after treatment
Title
Side and adverse effects
Description
any side/adverse effects related to study drugs such as hypotension, bradycardia, or anaphylaxis or local adverse effects such as pain or hematoma in the injection area
Time Frame
From start of performing drug to in the first 24 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition Patients whose pre-treatment VAS scores are more than 40 point. Patients who give written and verbal consent to include study. Exclusion Criteria: Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours Patients had a history of allergy to any of the drugs used in this study Patients used any anticoagulant-agents, Patients had bleeding diathesis patients were pregnant, patients were breastfeeding mothers Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease Patients had peptic ulcer Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl
Facility Information:
Facility Name
Kecioren Training and Research Hospital
City
Ankara
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

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Ibuprofen in Migraine Patients

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