a comparison of analgesic i̇mpacts of piroxicam and diclofenac sodium in the treatment of primary dysmenorrhea

Conditions: Primary Dysmenorrhea

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.

* 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.

Eligibility criteria:
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.

Keywords: dysmenorrhea piroxicam diclofenac sodium emergency department