Trial Outcomes & Findings for Geriatric Ketamine for Pain Management Study (NCT NCT02673372)

Last Updated: 2019-05-31

Results Overview

The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

30 minutes

Results posted on

2019-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine Group intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.	Ketamine Group Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min) Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Geriatric Ketamine for Pain Management Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine Group n=30 Participants intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.	Ketamine Group n=30 Participants Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min) Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	77.13 years STANDARD_DEVIATION 8.51 • n=5 Participants	77.27 years STANDARD_DEVIATION 8.44 • n=7 Participants	77.2 years STANDARD_DEVIATION 8.41 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	21 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Outcome measures
Measure	Morphine Group n=30 Participants intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.	Ketamine Group n=30 Participants Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min) Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
Reduction of Pain Score at 30 Minutes	4.4 score on a scale Standard Deviation 3.1	4.2 score on a scale Standard Deviation 3.4

Adverse Events

Morphine Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ketamine Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Morphine Group n=30 participants at risk intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. Morphine: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.	Ketamine Group n=30 participants at risk Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min) Ketamine: Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
General disorders Nausea	6.7% 2/30 • Number of events 2 • 30 minutes	6.7% 2/30 • Number of events 2 • 30 minutes

Additional Information

Sergey Motov, Director of Research

Maimonides Medical Center

Phone: 718-283-8693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place