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Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

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ClinicalTrials.gov Identifier: NCT01387139
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : February 17, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Procedural Sedation and Analgesia
Interventions Drug: Ketamine
Drug: Ketamine Co-administered with Propofol
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person) Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Period Title: Overall Study
Started 99 84
Completed 99 84
Not Completed 0 0
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 99 84 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 84 participants 183 participants
<=18 years
99
 100.0%
84
 100.0%
183
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 84 participants 183 participants
Female
25
  25.3%
30
  35.7%
55
  30.1%
Male
74
  74.7%
54
  64.3%
128
  69.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 84 participants 183 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.0%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   6.1%
10
  11.9%
16
   8.7%
White
72
  72.7%
62
  73.8%
134
  73.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
20
  20.2%
12
  14.3%
32
  17.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 99 participants 84 participants 183 participants
99 84 183
1.Primary Outcome
Title Frequency of Adverse Events
Hide Description We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
Time Frame From enrollment through completion of follow-up, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Measure Type: Number
Unit of Measure: participants
Respiratory depression 12 15
Cardiovascular event 1 0
vomiting/retching 21 18
Unpleasant recovery reaction 4 2
2.Secondary Outcome
Title Recovery Time
Hide Description Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
Time Frame Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Median (Inter-Quartile Range)
Unit of Measure: minutes
44
(19 to 69)
43.5
(17.5 to 67.5)
3.Secondary Outcome
Title Efficacy of Sedation
Hide Description

Efficacy is defined as:

  1. The patient does not have unpleasant recall of the procedure.
  2. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation
  3. The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.
  4. The procedure was successful
Time Frame After procedure is completed, on average less than 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Measure Type: Number
Unit of Measure: participants
97 81
4.Secondary Outcome
Title Parent Satisfaction
Hide Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Median (Inter-Quartile Range)
Unit of Measure: units on a scale (1-10)
10
(9 to 10)
10
(8 to 10)
5.Secondary Outcome
Title Physician Performing Procedure Satisfaction
Hide Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
9
(7 to 10)
8
(4 to 10)
6.Secondary Outcome
Title Nurse Satisfaction
Hide Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 99 84
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
10
(8 to 10)
8
(4 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/99 (0.00%)      0/84 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/99 (38.38%)      33/84 (39.29%)    
Cardiac disorders     
Cardiovascular event  1/99 (1.01%)  1 0/84 (0.00%)  0
Gastrointestinal disorders     
Vomiting  21/99 (21.21%)  21 18/84 (21.43%)  18
Psychiatric disorders     
Unpleasant recovery Reaction  4/99 (4.04%)  4 2/84 (2.38%)  2
Respiratory, thoracic and mediastinal disorders     
Respiratory depression   12/99 (12.12%)  12 15/84 (17.86%)  15
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keith Weisz
Organization: Ucolorado
Phone: 303-724-2592
EMail: keith.weisz@childrenscolorado.org
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01387139    
Other Study ID Numbers: 10-0835
First Submitted: May 20, 2011
First Posted: July 4, 2011
Results First Submitted: December 3, 2015
Results First Posted: February 17, 2016
Last Update Posted: December 8, 2017