DysmenorrheaNCT03697746
Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
A study testing paracetamol, Dexketoprofen Trometamol and Ibuprofen in people with Dysmenorrhea, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Our study will be performed on 300 patients who meet the criteria for joining the emergency service with primary dysmenorrhea. 3 drugs we will use: 1000 mg vial of paracetamol, dexketoprofen trometamol will be 50 mg ampoule and ibuprofen 400 mg vial According to the visual analog scale and visual visual scale, we will… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- paracetamol, Dexketoprofen Trometamol and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Apr 2019
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients with primary dysmenorrhea (abdomino-pelvic pain) between the ages of 18-45.
- The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding.
- Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form.
- Patients with visual analogue scale score> 5 and those who need or need nonsteroidal anti-inflammatory treatment.
Who cannot join
- Severe liver, kidney and heart failure; asthma, nasal polyp, angioedema and urticaria against aspirin or other nonsteroidal antiinflammatory drugs;
- Active peptic ulcer, bleeding or perforation; to have a history of upper gastrointestinal disease;
- Patients with phenylketonuria;
- During pregnancy and lactation;
- Have asthma;
- Have taken analgesics in the last 4 hours;
- The age of pregnancy and not using birth control method; digoxin, lithium, furosemide and other diuretics, acetylsalicylic acid and coumarin group using anticoagulants and physical examination of the suspicion of acute abdomen and signs of peritoneal irritation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, 20160
SEÇKİN ÇİFTÇİOĞLU, 05550619591, seckinozyer@hotmail.com
BÜLENT ERDUR, 296-6312 ext. 258, berdur@pau.edu.tr
About this study
Our study will be performed on 300 patients who meet the criteria for joining the emergency service with primary dysmenorrhea.
3 drugs we will use: 1000 mg vial of paracetamol, dexketoprofen trometamol will be 50 mg ampoule and ibuprofen 400 mg vial
According to the visual analog scale and visual visual scale, we will ask the patient to rate her pain between 0 (no pain) and 10 (the most severe pain of her life).
We aim to determine the superiority of the drugs in passing the pain randomly by giving the 3 drugs that we mentioned to patients with pain above 5.
Read the detailed description
Our research will be carried out in Pamukkale University Faculty of Medicine Department of Emergency Medicine in 12 months period. There will be a research assistant and / or a faculty member who will control the research for 24 hours in our emergency department with approximately 110000 adult patients / year.
Study criteria: Female patients with primary dysmenorrhea (abdomino-pelvic pain) in the 18-45 age range. The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding. Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form. Patients with a Visual Analog Scale > 5 and those who require or are recommended nonsteroid antiinflammatory treatment.Patients who come with dysmenorrhea will be randomly selected and will be divided into three groups according to the pre-planned drug administration.
Group 1; Paracetamol 1000 mg Group 2; Dexketoprofen Trometamol 50mg Group 3; Ibuprofen 400 mg In the form of group to be administered intravenously. In case of unresponsiveness to treatment, intravenous Tramadol hcl 100mg will be administered after 45 minutes.
Pain scores of patients will be recorded using the Visual Analog Scale, 0-10 cm Visual Analog Scale, to score the degree of pain.During the process, O2 saturation monitorization, automatic manometer (blood pressure), rhythm monitorization (speed and rhythm) will be provided and all other medications during the operation will be recorded.
Pain scores will be recorded at 0, 15, 30, 45 and 60 minutes. In addition, heart rate, systolic blood pressure, diastolic blood pressure, respiration rate and O2 saturation (SPO2) will be recorded at 0, 15, 30, 60 minutes.
In addition, any side effects that may occur are recorded in the data sheet. If side effects are necessary, treatment will be applied. All information will be saved to the created work form
- Conditions
- Dysmenorrhea
- Being tested
- paracetamol, Dexketoprofen Trometamol, Ibuprofen
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called Parol 1000 mg vial--Mefar medicine-İstanbul
paracetamol 1000 mg vial
Dexketoprofen TrometamolDrug
Also called Dexiren 50 mg bulb-İlko medicine-İdol
dexketoprofen trometamol 50 mg bulb
IbuprofenDrug
Also called İntrafen 400mg/4ml flakon-Gen medicine- Ankara
ıbuprofen 400 mg vial
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | 1000 mg Paracetamol vial intravenously Receives: Drug: paracetamol |
| Dexketoprofen Trometamol | Active comparator | 50 mg Dexketoprofen Trometamol vial intravenously Receives: Drug: Dexketoprofen Trometamol |
| Ibuprofen | Active comparator | 400 mg Ibuprofen vial intravenously Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ıtem pain intensity measure
the patient will be given medication and will be asked to score between 0 and 10 on a visual analog scale.(0=no pain, 10= pain as bad as can be) every 15 minutes within 1 hour
Measured: 1 hour
ıtem pain intensity measure
100 mg of tramadol hcl will be given when the patient's pain does not fall below 5 points on a visual analog scale.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seçkin çiftçioğlu, Pamukkale University
- Investigators
- SEÇKİN ÇİFTÇİOĞLU, Principal investigator, PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697746
- Sponsor's protocol ID
- Pamukkkale University
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
Letzel H, Megard Y, Lamarca R, Raber A, Fortea J. The efficacy and safety of aceclofenac versus placebo and naproxen in women with primary dysmenorrhoea. Eur J Obstet Gynecol Reprod Biol. 2006 Dec;129(2):162-8. doi: 10.1016/j.ejogrb.2006.01.004. Epub 2006 May 3.
PubMed 16675091Ayan M, Tas U, Sogut E, Arici S, Karaman S, Esen M, Demirturk F. [Comparing efficiencies of diclofenac sodium and paracetamol in patients with primary dysmenorrhea pain by using Visual Analog Scale]. Agri. 2013;25(2):78-82. doi: 10.5505/agri.2013.42103. Turkish.
PubMed 23720082Iacovides S, Baker FC, Avidon I. The 24-h progression of menstrual pain in women with primary dysmenorrhea when given diclofenac potassium: a randomized, double-blinded, placebo-controlled crossover study. Arch Gynecol Obstet. 2014 May;289(5):993-1002. doi: 10.1007/s00404-013-3073-8. Epub 2013 Nov 5.
PubMed 24190696
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03697746
- Acronym / sponsor ID
- Pamukkkale University
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 5 Oct 2018 (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.
Our study will be performed on 300 patients who meet the criteria for joining the emergency service with primary dysmenorrhea.
3 drugs we will use: 1000 mg vial of paracetamol, dexketoprofen trometamol will be 50 mg ampoule and ibuprofen 400 mg vial
According to the visual analog scale and visual visual scale, we will ask the patient to rate her pain between 0 (no pain) and 10 (the most severe pain of her life).
We aim to determine the superiority of the drugs in passing the pain randomly by giving the 3 drugs that we mentioned to patients with pain above 5.
Detailed description
Our research will be carried out in Pamukkale University Faculty of Medicine Department of Emergency Medicine in 12 months period. There will be a research assistant and / or a faculty member who will control the research for 24 hours in our emergency department with approximately 110000 adult patients / year.
Study criteria: Female patients with primary dysmenorrhea (abdomino-pelvic pain) in the 18-45 age range. The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding. Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form. Patients with a Visual Analog Scale > 5 and those who require or are recommended nonsteroid antiinflammatory treatment.Patients who come with dysmenorrhea will be randomly selected and will be divided into three groups according to the pre-planned drug administration.
Group 1; Paracetamol 1000 mg Group 2; Dexketoprofen Trometamol 50mg Group 3; Ibuprofen 400 mg In the form of group to be administered intravenously. In case of unresponsiveness to treatment, intravenous Tramadol hcl 100mg will be administered after 45 minutes.
Pain scores of patients will be recorded using the Visual Analog Scale, 0-10 cm Visual Analog Scale, to score the degree of pain.During the process, O2 saturation monitorization, automatic manometer (blood pressure), rhythm monitorization (speed and rhythm) will be provided and all other medications during the operation will be recorded.
Pain scores will be recorded at 0, 15, 30, 45 and 60 minutes. In addition, heart rate, systolic blood pressure, diastolic blood pressure, respiration rate and O2 saturation (SPO2) will be recorded at 0, 15, 30, 60 minutes.
In addition, any side effects that may occur are recorded in the data sheet. If side effects are necessary, treatment will be applied. All information will be saved to the created work form
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: paracetamol1000 mg Paracetamol vial intravenously |
| Dexketoprofen Trometamol | Active comparator | Drug: Dexketoprofen Trometamol50 mg Dexketoprofen Trometamol vial intravenously |
| Ibuprofen | Active comparator | Drug: Ibuprofen400 mg Ibuprofen vial intravenously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients with primary dysmenorrhea (abdomino-pelvic pain) between the ages of 18-45.
- The onset of symptoms should usually be a few hours - 1 day before the onset of visible vaginal bleeding.
- Possible systemic symptoms such as nausea, vomiting, diarrhea, headache, fatigue, irritability, and dizziness are also questioned and recorded in the data form.
- Patients with visual analogue scale score> 5 and those who need or need nonsteroidal anti-inflammatory treatment.
Key exclusion criteria (7 listed)
- Severe liver, kidney and heart failure; asthma, nasal polyp, angioedema and urticaria against aspirin or other nonsteroidal antiinflammatory drugs;
- Active peptic ulcer, bleeding or perforation; to have a history of upper gastrointestinal disease;
- Patients with phenylketonuria;
- During pregnancy and lactation;
- Have asthma;
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: Parol 1000 mg vial--Mefar medicine-İstanbulparacetamol 1000 mg vial | Drug | Paracetamol |
| Dexketoprofen TrometamolAlso: Dexiren 50 mg bulb-İlko medicine-İdoldexketoprofen trometamol 50 mg bulb | Drug | Dexketoprofen Trometamol |
| IbuprofenAlso: İntrafen 400mg/4ml flakon-Gen medicine- Ankaraıbuprofen 400 mg vial | Drug | Ibuprofen |
Primary outcome
ıtem pain intensity measure
Time frame: 1 hour
the patient will be given medication and will be asked to score between 0 and 10 on a visual analog scale.(0=no pain, 10= pain as bad as can be) every 15 minutes within 1 hour
ıtem pain intensity measure
Time frame: 15 minute
100 mg of tramadol hcl will be given when the patient's pain does not fall below 5 points on a visual analog scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 16675091Letzel H, Megard Y, Lamarca R, Raber A, Fortea J. The efficacy and safety of aceclofenac versus placebo and naproxen in women with primary dysmenorrhoea. Eur J Obstet Gynecol Reprod Biol. 2006 Dec;129(2):162-8. doi: 10.1016/j.ejogrb.2006.01.004. Epub 2006 May 3.
- Background: PubMed 23720082Ayan M, Tas U, Sogut E, Arici S, Karaman S, Esen M, Demirturk F. [Comparing efficiencies of diclofenac sodium and paracetamol in patients with primary dysmenorrhea pain by using Visual Analog Scale]. Agri. 2013;25(2):78-82. doi: 10.5505/agri.2013.42103. Turkish.
- Background: PubMed 24190696Iacovides S, Baker FC, Avidon I. The 24-h progression of menstrual pain in women with primary dysmenorrhea when given diclofenac potassium: a randomized, double-blinded, placebo-controlled crossover study. Arch Gynecol Obstet. 2014 May;289(5):993-1002. doi: 10.1007/s00404-013-3073-8. Epub 2013 Nov 5.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
SEÇKİN ÇİFTÇİOĞLU principal investigator
PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol, Dexketoprofen Trometamol and Ibuprofen in people with Dysmenorrhea, 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 7 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 5 Oct 2018. 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.
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?
Contact SEÇKİN ÇİFTÇİOĞLU (05550619591, seckinozyer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ıtem pain intensity measure (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697746, which also lists 3 linked publications.
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 5 Oct 2018.