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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
Sponsor:
Information provided by (Responsible Party):
seçkin çiftçioğlu, Pamukkale University

Brief 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 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

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Active Comparator: Paracetamol
1000 mg Paracetamol vial intravenously
Drug: paracetamol
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
Drug: Ibuprofen
ıbuprofen 400 mg vial
Other Name: İntrafen 400mg/4ml flakon-Gen medicine- Ankara




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03697746


Contacts
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Contact: SEÇKİN ÇİFTÇİOĞLU 05550619591 seckinozyer@hotmail.com
Contact: BÜLENT ERDUR 296-6312 ext 258 berdur@pau.edu.tr

Locations
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Turkey
Pamukkale University Not yet recruiting
Deni̇zli̇, Turkey, 20160
Contact: SEÇKİN ÇİFTÇİOĞLU    05550619591    seckinozyer@hotmail.com   
Contact: BÜLENT ERDUR    296-6312 ext 258    berdur@pau.edu.tr   
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: SEÇKİN ÇİFTÇİOĞLU PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE

Publications:
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Responsible Party: seçkin çiftçioğlu, Emergency Medicine, Pamukkale University
ClinicalTrials.gov Identifier: NCT03697746     History of Changes
Other Study ID Numbers: Pamukkkale University
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: data will be available within 1 year of study completion
Access Criteria: data access requests will be reviewed by on external independent review panel requestors will be required to sign a data access agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Dexketoprofen trometamol
Ketoprofen
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