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

Primary Dysmenorrhea Clinical Trial

Official title: A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial

Status Completed

Clinical Trial Summary

• 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

• NCT number: NCT02253446
• Study type: Interventional
• Source: Pamukkale University
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Completion date: July 2014