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Nebulized Sub-dissociative Dose Ketamine for Treating 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: NCT03909607
Recruitment Status : Completed
First Posted : April 10, 2019
Results First Posted : May 3, 2022
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:

The investigators previous research study comparing the efficacy of intravenous ketamine to morphine showed ketamine to provide equivalent relief of moderate to severe acute pain in emergency department patients. A second study by the investigators showed that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the adverse effects experienced by recipients of ketamine.

The investigators now aim to see if nebulized subdissociative-dose ketamine administered as a single agent in a dose of 1.5 mg/kg via Breath-Actuated Nebulizers (BAN) over 5-15 minutes will provide a better pain relief in comparison to 1 mg/kg and 0.75 mg/kg doses or if the lower doses are equally as effective.


Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine 0.75 mg/kg Drug: Ketamine 1.0 mg/kg Drug: Ketamine 1.5 mg/kg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute and Chronic Painful Conditions in the ED: A Prospective, Randomized Trial
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: SDK 0.75 mg/kg
The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k
Drug: Ketamine 0.75 mg/kg
Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg

Active Comparator: SDK 1.0 mg/kg
The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k
Drug: Ketamine 1.0 mg/kg
Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg

Active Comparator: SDK 1.5 mg/kg
The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k
Drug: Ketamine 1.5 mg/kg
Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg




Primary Outcome Measures :
  1. Change in Pain Score at 30 Minutes [ Time Frame: 30 minutes ]
    Patients will be assessed via an 11 point Likert numeric rating scale at time medication is give and 30 minutes later. The difference in pain scores will be assessed between the 3 groups. The numeric rating scale range is from 0 to 10 with 0 being no pain and 10 being very severe pain.



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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 age 18 and older
  • acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as well as cancer pain
  • initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

Exclusion Criteria:

  • altered mental status,
  • allergy to ketamine,
  • weight greater than 150 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)
  • alcohol or drug abuse
  • inability to provide consent
  • psychiatric illness (schizophrenia),
  • recent (4 hours before) opioid use.

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): NCT03909607


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:
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Responsible Party: Antonios Likourezos, Research Manager; co-investigator, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03909607    
Other Study ID Numbers: 2018-11-12
First Posted: April 10, 2019    Key Record Dates
Results First Posted: May 3, 2022
Last Update Posted: May 3, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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