Pre-hospital Nebulized Ketamine for Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04162028|
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : February 28, 2020
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Nebutlized Ketamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-hospital Utilization of Nebulized Sub-dissociative Dose Ketamine for Managing Acute Traumatic Extremity Pain: a Prospective Observational Study|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Nebulized Ketamine
sub-dissociative dose ketamine administered prehospitally via breath-actuated nebulizer at 1.0 mg/kg for patients with acute pain
Drug: Nebutlized Ketamine
The PK-BAN package will be opened and weight -based dose of ketamine will be administered to the patient via BAN. The medication will be delivered with a minimum time of 5 min and maximum time of 15 min.
Other Name: ketamine
- Change in Pain Scores [ Time Frame: 30 minutes ]The primary outcome will include a percentage of patients achieving a 20% or greater change in pain scores on numeric rating pain scale (NRS) ranging form 0 no pain to 20 severe pain for the baseline to 30 minutes post-analgesic administration.
- Rescue Analgesia [ Time Frame: 30 minutes ]The secondary outcomes will include a need for second or third dose, a need for rescue analgesia at either 15 and 30 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162028
|Contact: Antonios Liikourezos, MPHemail@example.com|
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Antonios Likourezos, MPH 718-283-6896 firstname.lastname@example.org|