Pre-hospital Nebulized Ketamine for Pain

NCT04162028 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2018-10-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores

  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.

  30 minutes

Secondary Outcomes (1)

• Rescue Analgesia

  30 minutes

Study Arms (1)

Nebulized Ketamine

EXPERIMENTAL

sub-dissociative dose ketamine administered prehospitally via breath-actuated nebulizer at 1.0 mg/kg for patients with acute pain

Drug: Nebutlized Ketamine

Interventions

Nebutlized Ketamine DRUG

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.

Also known as: ketamine

Nebulized Ketamine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 13, 2019
• Study Start: January 15, 2019
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

US (1)