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

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Ketamine; Morphine

Criteria

Inclusion Criteria:

• Age 18-70

• Self-report pain greater than or equal to 7/10 on a numerical-verbal scale

• Weigh 50-100 kg

• Have systolic blood pressure of 90-180 mmHg

• Have an ASA (American Society of Anaesthesiologists' classification) score of 1-2

Exclusion Criteria:

• Have had opioid analgesia administered within 6 hours of the study

• Are chronic analgesia users (of opioid or others)

• Have known allergies to morphine or ketamine

• Are pregnant

• Have a psychiatric history