NCT02253446

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Primary Dysmenorrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-10-01
• Last updated: 2014-10-01

Locations

1 site across 1 country: Turkey (Türkiye)