NCT04372264

Brief Summary

  • Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Acute Migraine Attack Headache
  • The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of acute Migraine Attack Headache

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

October 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

April 29, 2020

Last Update Submit

October 26, 2020

Conditions

Headache, Migraine

Keywords

paracetamoldexketoprofenibuprofenemergency departmentmigraine attack headache

Outcome Measures

Primary Outcomes (1)

  • Decrement of the pain on VAS

    Comparison of the reduction of Migraine Attack Headache VAS (visual analog scale) score between the three groups. - (First group Paracetamol, Second Dexketoprofen and Third Ibuprofen )

    Baseline and 60 minutes

Study Arms (3)

Paracetamol

EXPERIMENTAL

1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb\_UK) intravenous (IV) was given 70 patients,

Drug: Paracetamol

Dexketoprofen

EXPERIMENTAL

Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,

Drug: Dexketoprofen

Ibuprofen

EXPERIMENTAL

third group: 400 mg Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.

Drug: Ibuprofen

Interventions

ParacetamolDRUG

1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb\_UK) intravenous (IV) was given 70 patients,

Also known as: Perfalgan
Paracetamol
DexketoprofenDRUG

Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,

Also known as: ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Dexketoprofen
IbuprofenDRUG

third group: 400 mg Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.

Also known as: İntrafen
Ibuprofen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated Migraine Attack Headache
  • Patients who agree to work and receive the approval
  • VAS (visual analog scale) score\>5.

You may not qualify if:

  • Patients with severe liver, kidney,pulmonary and cardiac heartfailure
  • To be Pregnancy and breast-feeding
  • Have received analgesics in the last 6hours
  • Patients of childbearing age who are not using a birth control method.
  • Patients with neurological deficits
  • Patients with cardiac chest pain
  • Patients with chronic pain
  • Patients with pre-existing ibuprofen, dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
  • Patients with reflected pain
  • Patients with neoplastic pain
  • Patients with an allergy trait (ibuprofen, paracetamol and dexketoprofen)
  • Illiterates and patients with vision problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine DisordersEmergencies

Interventions

Acetaminophendexketoprofen trometamolIbuprofen

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • İbrahim Turkcuer

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

October 15, 2018

Primary Completion

May 29, 2020

Study Completion

December 29, 2020

Last Updated

October 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)