Comparision of clinical efficacy of Intravenous acetaminophen vs ketorolac to relieve pain in renal colic

The aim of this single blinded randomized controlled trial (for patients) is to determine and comparison of clinical efficacy of Intravenous acetaminophen vs. ketorolac to relieve pain in renal colic. We will study a sample of patients aged 18 to 55 who presented to the emergency department of Kosar hospital in Semnan, Iran. Patients will eligible for inclusion with a history of unilateral abdominal or flank pain that the treating emergency physicians suspect to be renal colic, with ultrasonography or CT scan or intravenous pyelography (IVP) findings consistent with the diagnosis of renal colic or passage of the calculus. Only patients displaying at least a visual analog scale (VAS) ≥30/100 will include. Patients cannot be include if they have a history of peptic ulcer disease, asthma, bleeding disorder (including the use of oral anticoagulant), impaired renal or hepatic function, suspected hypersensivity to aspirin or NSAID or paracetamol, and if they are pregnant and breast-feeding women. Patients cannot be included if they have received painkillers within 6 hours before presentation and if they are younger than 18 and greater than 55 years old. We calculated that a sample size of 120 patients is necessary and they divided through randomized permuted blocks single blind into two groups.one group will receive 1 gram intravenous paracetamol and another group will receive 30 mg intravenous ketorolac. Rescue therapy is defined as the need of 5 mg intramuscular morphine if VAS at 60 minutes is more than 50% the initial VAS. The primary end point is pain relief at 60 minutes, defined as a decrease of VAS of 50% or more as compared to the initial value. The secondary end points are differences in VAS at 20, 40, 60 minutes and occurrence of side effects. A questionnaire is designed for record of demographic data and VAS points and side effects.

Semnan University of Medical Sciences