Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients who present with acute traumatic injuries in the pre-hospital setting or to the emergency department (ED) are treated with opioids, the current gold standard for severe acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory depression- which necessitates post medication administration continuous monitoring of patients. IV administration may be difficult or impossible to provide in a number of extreme circumstances. For these reasons, there is a constant search for alternate treatment options for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in our department in adults, in an open, prospective study (Shimonovich at al 2016), and warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and efficacious analgesic and is overall well received both by patients and physicians. Side effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic potential for pain reduction in trauma patients, pre-hospital patients, and battlefield injuries. The study we are conducting is designed to test and analyze the safety and efficacy of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when both medications are administered 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
• Collaborator: Medical Corps, Israel Defense Force
• Treatments: Ketamine; Morphine

Criteria

Inclusion Criteria:

• be 18-70 years old

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

• weigh 50-100 kg

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

• have systolic blood pressure of 90-160 mmHg

Exclusion Criteria:

• have had opioid analgesia administered within 2 hours of the study

• are chronic analgesia users (of opioid or others)

• have known allergies to morphine or ketamine

• have had a large meal within an hour prior to trauma

• are pregnant

• have a psychiatric history

• have nasal congestion, nasal trauma, epistaxis, or a deviated nasal septum

• have suffered any head or face trauma: any trauma that is manifested by an external mark in the face or skull.