A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Piroxicam; Diclofenac Sodium
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,; Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
Other intervention name(s): Feldene 20 mg/1 mL Solution injectable IM; DICLOMEC (Solution injectable IM); DIKLORON (Solution injectable IM ); MIYADREN (Solution injectable IM ); VOLTAREN (Solution injectable IM )
Intervention MeSH terms: Diclofenac; Piroxicam; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Piroxicam; Diclofenac Sodium; Emergency department