Ketamine Clinical Trials
Pre-hospital Utilization of Nebulized Sub-dissociative Dose Ketamine for Managing Acute Traumatic Extremity Pain: a Prospective Observational Study
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Organisation Name: Maimonides Medical Center
Overal Status: Withdrawn
Start Date: January 15, 2019
Last Update: July 30, 2021
Lead Sponsor: Antonios Likourezos
Brief Summary: In the situation when intravenous access is not readily available or unobtainable, or when prehospital delays to obtain intravenous access are not warranted, sub-dissociative dose ketamine can be administered via intranasal (IN) route. The data supporting IN is not set on the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. In addition, IN administration of SDK for adult patients in the ED requires a highly concentrated solution that is not routinely stock in the ED. Hence, another non-invasive route exists such as nebulization via a Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion.Conditions
Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing acute pain due to extremity trauma in the prehospital arena.
We aim to evaluate analgesic efficacy and safety of sub-dissociative dose ketamine administered prehospital via breath-actuated nebulizer at 1.0 mg/kg for patients with acute traumatic extremity injuries.
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