Effect of paracetamol and ketorolac versus paracetamol and ibuprofen on the pain in patients with renal colic: a triple-blind randomized clinical trial

To assess the effect of paracetamol and ketorolac versus paracetamol and ibuprofen on the pain in patients with renal colic

This is a triple-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients with renal colic referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients and data analyzer will be aware of the intervention.

Inclusion criteria: Age of 18 to 60 years, Renal colic, Pain score of 5 or higher, Conscious level equal to 15 Exclusion criteria: Pregnancy, Cardiovascular failure, Chronic liver failure, Renal failure, Anemia, Peritonitis, Hemodynamics unsuitability, Sensitivity to morphine or its extension, History of allergy to ketorolac or ibuprofen, Receiving analgesic medications in the past 6 hours

Intervention group 1: Intravenous injection of ketorolac 30 mg (manufactured by Alborz Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline. Intervention group 2: Intravenous injection of ibuprofen 400 mg (manufactured by Abidi Pharmaceutical Co.) with 10 ml distilled water plus intravenous infusion of paracetamol 1 g (manufactured by Abidi Pharmaceutical Co.) with 100 ml serum normal saline.

Primary outcome: The severity of renal colic

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple-blind.