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

NCT03697746 | Unknown

• 1 other identifier: Pamukkkale University
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  15 minute

Study Arms (3)

Paracetamol

ACTIVE COMPARATOR

1000 mg Paracetamol vial intravenously

Drug: paracetamol

Dexketoprofen Trometamol

ACTIVE COMPARATOR

50 mg Dexketoprofen Trometamol vial intravenously

Drug: Dexketoprofen Trometamol

Ibuprofen

ACTIVE COMPARATOR

400 mg Ibuprofen vial intravenously

Drug: Ibuprofen

Interventions

paracetamol DRUG

paracetamol 1000 mg vial

Also known as: Parol 1000 mg vial--Mefar medicine-İstanbul

Paracetamol

Dexketoprofen Trometamol DRUG

dexketoprofen trometamol 50 mg bulb

Also known as: Dexiren 50 mg bulb-İlko medicine-İdol

Dexketoprofen Trometamol

Ibuprofen DRUG

ıbuprofen 400 mg vial

Also known as: İntrafen 400mg/4ml flakon-Gen medicine- Ankara

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16675091 BACKGROUND

• 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.

  PMID: 23720082 BACKGROUND

• 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.

  PMID: 24190696 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Acetaminophen; dexketoprofen trometamol; Ibuprofen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• SEÇKİN ÇİFTÇİOĞLU

  PAMUKKALE UNİVERSİTY HOSPİTAL EMERGENCY MEDİCİNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEÇKİN ÇİFTÇİOĞLU

CONTACT

05550619591; seckinozyer@hotmail.com

BÜLENT ERDUR

CONTACT

296-6312; berdur@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 5, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

TU (1)