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

• 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.

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.