PIROXICAM FAST-DISSOLVING DOSAGE FORM VS DICLOFENAC SODIUM IN THE TREATMENT OF ACUTE RENAL COLIC - A DOUBLE-BLIND CONTROLLED TRIAL

Objective To assess the possible therapeutic effect of 40 mg sublingua l piroxicam (fast-dissolving dosage form, FDDF) compared with intramus cular 75 mg diclofenac, as a reference drug, on acute renal colic in a randomized, double-blind controlled clinical trial, Patients and meth ods Eighty patients were assigned to one of two treatment groups; one received an intramuscular injection with 0.2 mL distilled water and tw o sublingual tablets of 20 mg piroxicam FDDF, and the other received a n intramuscular injection with 75 mg diclofenac sodium and two subling ual tablets of placebo, Pain intensity was evaluated by the patient us ing a visual analogue scale and by the observers, Vital signs at basel ine and 30 min after the administration of the study drugs were also r ecorded, Results The overall efficacy of the treatment was 81%; nine p atients in the piroxicam and six in the diclofenac group (no significa nt difference) required rescue treatment, Compared with baseline level s, the pain relief was significant (P<0.001) at 30 min in both groups. Twenty-two patients in the piroxicam and 25 in the diclofenac group a ttained complete pain relief at 30 min, as evaluated by the observer i no significant difference), Both treatments were similarly effective i n decreasing vital signs, mainly systolic blood pressure, heart and re spiratory rates, However, when the percentage change was compared betw een the groups, piroxicam significantly decreased the respiratory rate (P<0.03), Conclusion Piroxicam FDDF is as effective as parenteral dic lofenac in emergency renal colic treatment, Furthermore, its ease of s ell-administration increases patient compliance and potential use in g eneral practice.