drugset / Trial / NCT04013958

Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic

NCT04013958

Phase 3 Unknown 100 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupTriple-blindSupportive care

Summary

Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. For these reasons, there is a constant search for a way to reduce the use of opioids. ketamine has been proven to augmented the analgesic effect of opioids, and thus reduce the use and adverse effects of opioids. Different studies about the use of Ketamine as a sedition agent have shown that Ketamine given IM versus IV has longer duration of effect with less adverse effects. The study we are conducting is designed to test and analyze the safety and efficacy of IV Ketamine with IV Morphine compared to IV Ketamine and morphine with IM placebo in a setting of acute pain due to, or suspected renal colic in the ED. When both ways of administration are given by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.

Timeline

Start
2019-08-01
Primary completion
2021-08-01
Completion
2021-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 0.1 mg/kg Intravenous
Comparator Ketamine Small molecule 0.3 mg/kg Intravenous
Comparator Morphine Other / unclassified 0.1 mg/kg Intravenous