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Geriatric Ketamine for Pain Management Study

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ClinicalTrials.gov Identifier: NCT02673372
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Morphine
Drug: Ketamine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Morphine Group Ketamine Group
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Morphine Group Ketamine Group Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
   6.7%
2
   6.7%
4
   6.7%
>=65 years
28
  93.3%
28
  93.3%
56
  93.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
77.13  (8.51) 77.27  (8.44) 77.2  (8.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
23
  76.7%
23
  76.7%
46
  76.7%
Male
7
  23.3%
7
  23.3%
14
  23.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
  23.3%
5
  16.7%
12
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.0%
1
   3.3%
4
   6.7%
White
11
  36.7%
21
  70.0%
32
  53.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
  30.0%
3
  10.0%
12
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Reduction of Pain Score at 30 Minutes
Hide Description 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)
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine Group Ketamine Group
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.4  (3.1) 4.2  (3.4)
Time Frame 30 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Morphine Group Ketamine Group
Hide Arm/Group Description

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 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.

All-Cause Mortality
Morphine Group Ketamine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Morphine Group Ketamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Morphine Group Ketamine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      2/30 (6.67%)    
General disorders     
Nausea  [1]  2/30 (6.67%)  2 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
[1]
Nausea at 30 minutes
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sergey Motov, Director of Research
Organization: Maimonides Medical Center
Phone: 718-283-8693
EMail: smotov@maimonidesmed.org
Publications:
Gibson SJ. Pain and ageing: a comparison of the pain experience over the adult life span. Prog Pain Res Manage. 2003;24:767-90.
Gibson SJ, Farrell M. What is different about pain in older people? Reviews in Analgesia. 2004;8:23-37.
Gibson SJ. Older Persons' Pain: what can we learn? Pain Clin Updat. 2006;14:1-4.
Layout table for additonal information
Responsible Party: Antonios Likourezos, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02673372     History of Changes
Other Study ID Numbers: 2015-10-14
2015-10-14 ( Other Identifier: Maimonides Medical Center )
First Submitted: February 1, 2016
First Posted: February 3, 2016
Results First Submitted: October 25, 2018
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019