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Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372264
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ibrahim Turkcuer, Pamukkale University

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

Condition or disease Intervention/treatment Phase
Headache, Migraine Drug: Paracetamol Drug: Dexketoprofen Drug: Ibuprofen Phase 4

Detailed Description:
  • This is the randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
  • A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital
  • Study personnel (emergency physicians and nurses) were trained before the study.
  • When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended, an eligibility checklist was completed by the attending physician.
  • If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Acute Migraine Attack Headache severity ratings with visual analog scale (VAS) were recorded.
  • The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
  • All patients eligible for the study were randomized to one of three groups:

First Group: 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients, Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.

In addition, intravenous metoclopramide was added to the threatment of patients with acute migraine attack headache.

Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study.

  • Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse. Patients received the paracetamol,dexketoprofen,ibuprofen medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered intravenously.
  • Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
  • One researcher blinded to patient allocation observed the whole procedure and recorded the acute migraine attack headache scores.
  • Patients in three groups received three types of medication in a similar manner, thus ensuring double blind.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Intravenous Paracetamol, Dexketoprofen and Ibuprofen on Visual Analogue Scale (VAS) in the Treatment of Acute Migraine Attack Headache in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : April 29, 2020
Estimated Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Paracetamol
1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
Drug: Paracetamol
1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
Other Name: Perfalgan

Experimental: Dexketoprofen
Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
Drug: Dexketoprofen
Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
Other Names:
  • ASEKET
  • DARKIN
  • DEXALGIN
  • DESTIYO
  • DEXCORIL

Experimental: Ibuprofen
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
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.
Other Name: İntrafen




Primary Outcome Measures :
  1. Decrement of the pain on VAS [ Time Frame: Baseline and 60 minutes ]
    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 )



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
  • Isolated Migraine Attack Headache
  • Patients who agree to work and receive the approval
  • VAS (visual analog scale) score>5.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372264


Locations
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Turkey
Pamukkale University
Denizli, Turkey, 20070
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: İbrahim Turkcuer Pamukkale University
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Responsible Party: Ibrahim Turkcuer, Professor, MD, Pamukkale University
ClinicalTrials.gov Identifier: NCT04372264    
Other Study ID Numbers: 2019TIPF006
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ibrahim Turkcuer, Pamukkale University:
paracetamol
dexketoprofen
ibuprofen
emergency department
migraine attack headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Dexketoprofen trometamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics