Comparison of Nebulized Ketamine to Intravenous Sub-Dissociative Dose Ketamine for Pain

NCT04947085 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2020-08-05
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine is a non-competitive N-methyl-D-aspartate (NMDA)/glutamate receptor complex antagonist that decreases pain by diminishing central sensitization, hyperalgesia, and "wind-up" phenomenon at the level of the spinal cord (dorsal ganglion) and central nervous system (1). Ketamine administration in sub-dissociative doses (SDK) of 0.1-0.3 mg/kg in pre-hospital settings and in the ED results in effective pain relief in patients with acute traumatic and non-traumatic pain, chronic non-cancer and cancer pain, and in patients with opioid-tolerant pain by virtue of providing anti-hyperalgesia, anti-allodynia, and anti-tolerance (2-4). Two commonly utilized routes of SDK administration in the ED include an intravenous route (intravenous push dose or short infusion) and intranasal route. In the situation when intravenous access is not readily available or unobtainable, and intranasal route is not feasible, another non-invasive route of ketamine administration such as inhalation via Breath-Actuated Nebulizer (BAN) is coming into the play. The BAN allows a controlled patient-initiated delivery of analgesics in titratable fashion. Nebulized administration of ketamine has been studied in the areas of acute postoperative pain management (post-intubational sore throat), in anesthesia (pre-medication for general anesthesia,) and in managing cancer pain, and status asthmaticus therapy. However, our research team has published a case series of 5 patients receiving nebulized ketamine for a variety of acute painful conditions and has recently completed a randomized double-blind trial of 120 adult patients that evaluated analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED. Currently, we are conducting two additional studies evaluating the role of nebulized ketamine in pediatric ED and pre-hospital arena. In this study the investigators hypothesize that intravenous sub-dissociative-dose ketamine of 0.3 mg/kg will provide better analgesia at 30 min post-medication administration in comparison to nebulized ketamine administered at 0.75 mg/kg. The primary outcome of this trial is the comparative reduction in participant's pain scores at 30 minutes post medication administration.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in in Pain Score at 30 Minutes

  The primary outcome of this trial is the comparative change in participant's pain scores at 30 minutes post medication administration. Pain score is measured in a 11 point Likert Scale where 0 is no pain and 10 is extreme pain; 5 is moderate pain.

  30 minutes

Study Arms (2)

IV SDK

ACTIVE COMPARATOR

intravenous ketamine administration in sub-dissociative doses (SDK) administered at 0.3 mg/kg over 15 minutes to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions.

Drug: Ketamine via Intravenous

K-BAN

ACTIVE COMPARATOR

nebulized ketamine at 0.75mg/kg administered via BAN to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions.

Drug: Ketamine via BAN

Interventions

Ketamine via Intravenous DRUG

Ketamine administration in sub-dissociative doses

IV SDK

Ketamine via BAN DRUG

Ketamine administered via Breath-Actuated Nebulizer (BAN)

K-BAN

Eligibility Criteria

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

You may qualify if:

• ED patients
• Patients 18 years of age
• acute and chronic painful conditions
• pain with a score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
• Patients will have to be awake, alert, and oriented to person, place, and time,
• Be able to demonstrate understanding of the informed consent process and content.
• Patients also will have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS.

You may not qualify if:

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

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sergey Motov
• Organization: Maimonides Medical Center

smotov@maimo.org

718-283-6000

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: October 4, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)