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Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia (KPSF)

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ClinicalTrials.gov Identifier: NCT01325493
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : November 2, 2015
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Idiopathic Scoliosis
Spondylolisthesis
Interventions Drug: Ketamine
Drug: Normal Saline
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Saline
Hide Arm/Group Description Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1. Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Period Title: Overall Study
Started 30 24
Completed 29 21
Not Completed 1 3
Reason Not Completed
Protocol Violation             0             1
loss of neuromonitoring signals             0             2
Allergy             1             0
Arm/Group Title Ketamine Saline Total
Hide Arm/Group Description Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1. Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1. Total of all reporting groups
Overall Number of Baseline Participants 29 21 50
Hide Baseline Analysis Population Description
ASA classifications: ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 21 participants 50 participants
14
(11 to 18)
14
(12 to 18)
14
(11 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 21 participants 50 participants
Female
24
  82.8%
14
  66.7%
38
  76.0%
Male
5
  17.2%
7
  33.3%
12
  24.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 21 participants 50 participants
29 21 50
American Society of Anesthesiology classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 21 participants 50 participants
ASA 1 13 14 27
ASA 2 15 7 22
ASA 3 1 0 1
[1]
Measure Description: ASA classifications: ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease
1.Primary Outcome
Title Morphine Equivalent Consumption (mg/kg)
Hide Description Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.
Time Frame at 24, 48, 72, 96 hours post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group Description:
Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Number of Participants Analyzed 29 21
Mean (Standard Deviation)
Unit of Measure: mg/kg
24 hrs after surgery 1.3  (.3) 1.36  (.42)
48 hrs after surgery 1.28  (.26) 1.275  (.31)
72 hrs after surgery .89  (.55) .93  (.36)
96 hrs after surgery .57  (.44) .38  (.35)
2.Secondary Outcome
Title Sedation Score
Hide Description

Sedation scores 0 = completely awake

  1. = sleepy but responds appropriately
  2. = somnolent but arouses to light stimuli
  3. = asleep but responsive to deeper physical stimuli
  4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.
Time Frame 24, 48, 72, 96 hours post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group Description:
Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Number of Participants Analyzed 29 21
Mean (Standard Deviation)
Unit of Measure: Sedation Score
24 hrs after surgery .73  (.68) .75  (.73)
48 hrs after surgery .62  (.8) .54  (.85)
72 hrs after surgery .38  (.45) .3  (.84)
96 hrs after surgery .24  (.43) .21  (.39)
3.Secondary Outcome
Title Pain Score at Rest
Hide Description Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.
Time Frame 24, 48, 72, 96 hours post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group Description:
Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Number of Participants Analyzed 29 21
Mean (Standard Deviation)
Unit of Measure: pain score at rest
24 hrs after surgery 3.9  (2.1) 4.55  (2.0)
48 hrs after surgery 4.53  (1.69) 5.2  (2.2)
72 hrs after surgery 3.6  (2.3) 3.48  (2.0)
96 hrs after surgery 4.48  (2.1) 3.8  (1.8)
4.Secondary Outcome
Title Pain Score During Cough.
Hide Description Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.
Time Frame 24, 48, 72, 96 hours post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Saline
Hide Arm/Group Description:
Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Number of Participants Analyzed 29 21
Mean (Standard Deviation)
Unit of Measure: pain score at cough
24 hrs after surgery 4.5  (2.5) 5.1  (3.0)
48 hrs after surgery 5.4  (2.3) 5.45  (2.7)
72 hrs after surgery 4.4  (2.3) 3.7  (2.5)
96 hrs after surgery 5.15  (2.5) 4.2  (2)
Time Frame the duration of the study (96 hrs) post surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Saline
Hide Arm/Group Description Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1. Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
All-Cause Mortality
Ketamine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      0/21 (0.00%)    
Surgical and medical procedures     
Allergy * [1]  1/29 (3.45%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Morphine allergy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/21 (0.00%)    
Patient sex and ethnicity could have led to analytical bias.
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: Julia Finkel
Organization: Children's National Health System
Phone: 2024764867
EMail: JFINKEL@childrensnational.org
Layout table for additonal information
Responsible Party: Julia Finkel, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01325493     History of Changes
Other Study ID Numbers: 4735
First Submitted: February 25, 2011
First Posted: March 29, 2011
Results First Submitted: June 17, 2015
Results First Posted: November 2, 2015
Last Update Posted: January 14, 2016