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Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
paracetamol
Dexketoprofen Trometamol
Ibuprofen
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Paracetamol

Dexketoprofen Trometamol

Ibuprofen

Arm Description

1000 mg Paracetamol vial intravenously

50 mg Dexketoprofen Trometamol vial intravenously

400 mg Ibuprofen vial intravenously

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2018
Last Updated
October 4, 2018
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT03697746
Brief Title
Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
Official Title
Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
April 1, 2019 (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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
1000 mg Paracetamol vial intravenously
Arm Title
Dexketoprofen Trometamol
Arm Type
Active Comparator
Arm Description
50 mg Dexketoprofen Trometamol vial intravenously
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
400 mg Ibuprofen vial intravenously
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Parol 1000 mg vial--Mefar medicine-İstanbul
Intervention Description
paracetamol 1000 mg vial
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen Trometamol
Other Intervention Name(s)
Dexiren 50 mg bulb-İlko medicine-İdol
Intervention Description
dexketoprofen trometamol 50 mg bulb
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
İntrafen 400mg/4ml flakon-Gen medicine- Ankara
Intervention Description
ıbuprofen 400 mg vial
Primary Outcome Measure Information:
Title
ıtem pain intensity measure
Description
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
Time Frame
1 hour
Title
ıtem pain intensity measure
Description
100 mg of tramadol hcl will be given when the patient's pain does not fall below 5 points on a visual analog scale.
Time Frame
15 minute

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEÇKİN ÇİFTÇİOĞLU
Phone
05550619591
Email
seckinozyer@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
BÜLENT ERDUR
Phone
296-6312
Ext
258
Email
berdur@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEÇKİN ÇİFTÇİOĞLU
Organizational Affiliation
PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Deni̇zli̇
ZIP/Postal Code
20160
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SEÇKİN ÇİFTÇİOĞLU
Phone
05550619591
Email
seckinozyer@hotmail.com
First Name & Middle Initial & Last Name & Degree
BÜLENT ERDUR
Phone
296-6312
Ext
258
Email
berdur@pau.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
data will be available within 1 year of study completion
IPD Sharing Access Criteria
data access requests will be reviewed by on external independent review panel requestors will be required to sign a data access agreement
Citations:
PubMed Identifier
16675091
Citation
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.
Results Reference
background
PubMed Identifier
23720082
Citation
Ayan 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.
Results Reference
background
PubMed Identifier
24190696
Citation
Iacovides 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.
Results Reference
background

Learn more about this trial

Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea

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