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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162028
Recruitment Status : Withdrawn (Investigators not interested any more in the study)
First Posted : November 13, 2019
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 28, 2021
Actual Study Completion Date : July 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age and older
  • acute traumatic extremities injuries
  • a score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

Exclusion Criteria:

  • Patients with altered mental status,
  • allergy to ketamine, pregnant patients,
  • weight greater than 100 kg,
  • unstable vital signs (systolic blood pressure <90 or>180 mm Hg,
  • pulse rate <50 or >150 beats/min,
  • respiration rate <10 or >30 breaths/min),
  • inability to consent,
  • past medical history of alcohol or drug abuse
  • schizophrenia.

Information from the National Library of Medicine

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


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:
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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT04162028    
Other Study ID Numbers: 2018-10-08
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action