A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea

Overview

– Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Primary Dysmenorrhea. – The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's pain reduction dysmenorrhea in emergency department (ED) adults. – The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours after discharge.

Full Title of Study: “A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2014

Detailed Description

– this is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting. – A randomized clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital – Study personnel (emergency physicians and nurses) were trained before the study. – When intramuscular drugs (Piroxicam, Diclofenac sodium) was being recommended, an eligibility checklist was completed by the attending physician. – If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial Dysmenorrhea pain severity ratings with VAS were recorded. – The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients. – All patients eligible for the study were randomized to one of two groups: – First Group: 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients, – Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients which determined to be applied as a group. – Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not involved in the study. – Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations – The allocation list was kept by the emergency nurse. Patients received the piroxicam, diclofenac sodium medication schemes according to their random allocations. – After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered as a intramuscular. – Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms) – One researcher blinded to patient allocation observed the whole procedure and recorded the Dysmenorrhea pain scores. – Patients in both groups received two types of medication in a similar manner, thus ensuring double blinding. – Dysmenorrhea pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10 – Rescue medication (100 mg of tramadol hydrochloride) was given intramuscular to patients if pain VAS scores ≥ 5 in forty five minutes after study drug administration. – All other medications required during the study also were recorded. – During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

Interventions

  • Drug: Piroxicam
    • 20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,
  • Drug: Diclofenac Sodium
    • Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Arms, Groups and Cohorts

  • Experimental: Piroksikam
    • 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,
  • Experimental: Diclofenac Sodium
    • Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Clinical Trial Outcome Measures

Primary Measures

  • Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. – (First group Piroxicam and Second Diclofenac Sodium)
    • Time Frame: Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes.

Participating in This Clinical Trial

Inclusion Criteria

  • patients were eligible for inclusion if they were aged 18 years or older, 45 years or younger – had Primary Dysmenorrhea – VAS (visual analog scale) score >5. Exclusion Criteria:

  • Patients with severe liver, kidney and heart failure – After the use of aspirin or other nonsteroidal antiinflammatory drugs, asthma, nasal polyps, angioedema and urticaria to be seen – To have active peptic ulcer bleeding or perforation – Have a history of upper gastrointestinal disease – The presence of Phenylketonuria disease – To be Pregnancy and breast-feeding – To be Asthma patients – Have received analgesics in the last 4 hours – Patients of childbearing age who are not using a birth control method. – The patient who using digoxin, lithium, furosemide and other diuretics, acetylsalicylic acid and anticoagulant coumadin – Physical examination and suspected acute abdomen.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pamukkale University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bulent Erdur, professor – Pamukkale University
  • Overall Official(s)
    • Mehpare camlibel, MD, Principal Investigator, pamukkale universty

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