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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01387139
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : February 17, 2016
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Ketamine Alone 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 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)

Participant Flow:   Overall Study
    Ketamine Alone   Ketamine Co-Administered With Propofol
STARTED   99   84 
COMPLETED   99   84 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Ketamine Alone No text entered.
Ketamine Co-Administered With Propofol No text entered.
Total Total of all reporting groups

Baseline Measures
   Ketamine Alone   Ketamine Co-Administered With Propofol   Total 
Overall Participants Analyzed 
[Units: Participants]
 99   84   183 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
Female      25  25.3%      30  35.7%      55  30.1% 
Male      74  74.7%      54  64.3%      128  69.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
United States   99   84   183 

  Outcome Measures

1.  Primary:   Frequency of Adverse Events   [ Time Frame: From enrollment through completion of follow-up, up to 7 days ]

2.  Secondary:   Recovery Time   [ Time Frame: Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour ]

3.  Secondary:   Efficacy of Sedation   [ Time Frame: After procedure is completed, on average less than 1 hour ]

4.  Secondary:   Parent Satisfaction   [ Time Frame: After procedure is completed, on average less than 1 hour ]

5.  Secondary:   Physician Performing Procedure Satisfaction   [ Time Frame: After procedure is completed, on average less than 1 hour ]

6.  Secondary:   Nurse Satisfaction   [ Time Frame: After procedure is completed, on average less than 1 hour ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Keith Weisz
Organization: Ucolorado
phone: 303-724-2592
e-mail: keith.weisz@childrenscolorado.org


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01387139     History of Changes
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