Nebulized Sub-dissociative Dose Ketamine for Treating Pain
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Apr 2019
Typical duration for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedStudy Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
May 3, 2022
CompletedJune 15, 2022
April 1, 2022
1.5 years
April 4, 2019
April 7, 2022
May 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Scores From Baseline to 30 Minutes
Patients will be assessed via an 11 point Likert numeric rating scale at time medication is given (baseline) 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.
30 minutes
Study Arms (3)
SDK 0.75 mg/kg
ACTIVE COMPARATORThe patients will receive sub-dissociative ketamine at a dose of 0.75mg/k
SDK 1.0 mg/kg
ACTIVE COMPARATORThe patients will receive sub-dissociative ketamine at a dose of 1.0mg/k
SDK 1.5 mg/kg
ACTIVE COMPARATORThe patients will receive sub-dissociative ketamine at a dose of 1.5mg/k
Interventions
Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg
Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg
Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sergey Motov MD
- Organization
- Maimonides Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sergey Motov, MD
Maimonides Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Manager; co-investigator
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 10, 2019
Study Start
April 16, 2019
Primary Completion
October 30, 2020
Study Completion
June 30, 2021
Last Updated
June 15, 2022
Results First Posted
May 3, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share