Headache, MigrainePhase 4NCT04372264
Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache
A Phase 4 study testing Paracetamol, Dexketoprofen and Ibuprofen in people with Headache, Migraine, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Paracetamol, Dexketoprofen and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 29 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
Read the 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.
- Conditions
- Headache, Migraine
- Being tested
- Paracetamol, Dexketoprofen, Ibuprofen
- Keywords
- paracetamol, dexketoprofen, ibuprofen, emergency department, migraine attack headache
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
DexketoprofenDrug
Also called ASEKET, DARKIN, DEXALGIN, DESTIYO
Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
IbuprofenDrug
Also called İntrafen
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.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients, Receives: Drug: Paracetamol |
| Dexketoprofen | Experimental | Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients, Receives: 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. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Baseline and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start15 Oct 2018
- Primary completion29 May 2020
- Study completion29 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Turkcuer, Pamukkale University
- Investigators
- İbrahim Turkcuer, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372264
- Sponsor's protocol ID
- 2019TIPF006
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04372264
- Acronym / sponsor ID
- 2019TIPF006
- Conditions
- Headache, Migraine
- Keywords
- paracetamol, dexketoprofen, ibuprofen, emergency department, migraine attack headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 Dec 2020 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: Paracetamol1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients, |
| Dexketoprofen | Experimental | Drug: DexketoprofenSecond Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients, |
| Ibuprofen | Experimental | Drug: Ibuprofenthird group: 400 mg Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Perfalgan1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients, | Drug | Paracetamol |
| DexketoprofenAlso: ASEKET, DARKIN, DEXALGIN, DESTIYOSecond Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients, | Drug | Dexketoprofen |
| IbuprofenAlso: İntrafenthird 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 |
Primary outcome
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 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İbrahim Turkcuer principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol, Dexketoprofen and Ibuprofen in people with Headache, Migraine, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrement of the pain on VAS (time frame: Baseline and 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.