Compression of intranasal ketamine, intranasal fentanyl adjunct to intravenous ketorolac on renal colic pain relief: A Randomized Clinical Trial

Compression of intranasal ketamine, intranasal fentanyl adjunct to intravenous ketorolac on renal colic pain relief

Randomized control trial, randomization by random schedule, double blinded, 3 parallel groups (40 patients in each group)

120 patients admitted to the emergency department of Shahid Sadoughi and Shahid Rahnemoon hospitals in Yazd based on inclusion and exclusion criteria will be randomly allocated into three groups: Group A: 1 milligram per kilogram intranasal ketamine and 30 milligrams intravenous ketorolac, group B: 1 microgram per kilogram intranasal fentanyl and 30 milligrams intravenous ketorolac and for group C nasal placebo spray and 30 milligrams intravenous ketorolac will be prescribed and the severity of pain (by Visual Analogue Scale score) and complications of drugs will be determined in 0, 5, 10, 15, 30 and 60 minutes. The drugs will be prescribed by a triage nurse and none of patients nor physician won't know which drug was to be prescribed.

All 15 to 64 years old patients suspected for renal colic and urolithiasis based on urine analysis and imaging (ultrasonography or CT scan) , history and physical examination; Pregnancy, fever, hemodynamic instability, allergy or addiction to prescribed medication, nasal congestion, history of renal, cardiac or hepatic failure, brain tumor, glaucoma, peptic ulcer and psychosis, consumption of analgesic drugs in 4 last hours, VAS score below 5

Group A: 1 milligram per kilogram intranasal ketamine (maximum 50 milligrams) and 30 milligrams intravenous ketorolac Group B: 1 microgram per kilogram intranasal fentanyl (maximum 50 micrograms) and 30 milligrams intravenous ketorolac Group C: nasal placebo spray and 30 milligrams intravenous ketorolac

Severity of pain measured by Visual Analogue Scale

Individual simple randomization Based on a random sequence of numbers from Random.org, a table will be prepared, with the first forty consecutive numbers in Group A, the next forty consecutive numbers in Group B, and the final forty consecutive numbers in Group C. These numbers will be assigned to each patient in order of admission.

The drug will be prescribed by a triage nurse, according to random number generator and none of the patients nor physician won't know which drug was to be prescribed.