Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache
Primary Purpose
Headache, Migraine
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Dexketoprofen
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Migraine focused on measuring paracetamol, dexketoprofen, ibuprofen, emergency department, migraine attack headache
Eligibility 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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Paracetamol
Dexketoprofen
Ibuprofen
Arm Description
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 Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.
Outcomes
Primary Outcome Measures
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 )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04372264
Brief Title
Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
December 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
paracetamol, dexketoprofen, ibuprofen, emergency department, migraine attack headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
Arm Title
Dexketoprofen
Arm Type
Experimental
Arm Description
Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Intervention Description
Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
İntrafen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrement of the pain on VAS
Description
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 )
Time Frame
Baseline and 60 minutes
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim Turkcuer
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache
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