Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
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|ClinicalTrials.gov Identifier: NCT03697746|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dysmenorrhea||Drug: paracetamol Drug: Dexketoprofen Trometamol Drug: Ibuprofen||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2019|
Active Comparator: Paracetamol
1000 mg Paracetamol vial intravenously
paracetamol 1000 mg vial
Other Name: Parol 1000 mg vial--Mefar medicine-İstanbul
Active Comparator: Dexketoprofen Trometamol
50 mg Dexketoprofen Trometamol vial intravenously
Drug: Dexketoprofen Trometamol
dexketoprofen trometamol 50 mg bulb
Other Name: Dexiren 50 mg bulb-İlko medicine-İdol
Active Comparator: Ibuprofen
400 mg Ibuprofen vial intravenously
ıbuprofen 400 mg vial
Other Name: İntrafen 400mg/4ml flakon-Gen medicine- Ankara
- 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.
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): NCT03697746
|Contact: SEÇKİN ÇİFTÇİOĞLUemail@example.com|
|Contact: BÜLENT ERDUR||296-6312 ext firstname.lastname@example.org|
|Pamukkale University||Not yet recruiting|
|Deni̇zli̇, Turkey, 20160|
|Contact: SEÇKİN ÇİFTÇİOĞLU 05550619591 email@example.com|
|Contact: BÜLENT ERDUR 296-6312 ext 258 firstname.lastname@example.org|
|Principal Investigator:||SEÇKİN ÇİFTÇİOĞLU||PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE|