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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03697746
• Other study ID #: Pamukkkale University
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2018
• Source: Pamukkale University
• Contact: SEÇKIN ÇIFTÇIOGLU
• Phone: 05550619591
• Email: seckinozyer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• paracetamol
paracetamol 1000 mg vial
• Dexketoprofen Trometamol
dexketoprofen trometamol 50 mg bulb
• Ibuprofen
ibuprofen 400 mg vial

Locations

Country	Name	City	State
Turkey	Pamukkale University	Deni?zli?

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ayan M, Tas U, Sögüt E, Arici S, Karaman S, Esen M, Demirtürk 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. — View 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. — View Citation

Letzel H, Mégard 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. Epub 2006 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	item 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	1 hour
Primary	item 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.	15 minute