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

This study has been completed.
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01387139
First received: May 20, 2011
Last updated: January 20, 2016
Last verified: January 2016
Results First Received: December 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Procedural Sedation and Analgesia
Interventions: Drug: Ketamine
Drug: Ketamine Co-administered with Propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  99     84     183  
Age  
[units: participants]
     
<=18 years     99     84     183  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     25     30     55  
Male     74     54     128  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     10     16  
White     72     62     134  
More than one race     0     0     0  
Unknown or Not Reported     20     12     32  
Region of Enrollment  
[units: participants]
     
United States     99     84     183  



  Outcome Measures
  Show All 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
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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
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  More Information
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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


Publications:


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01387139     History of Changes
Other Study ID Numbers: 10-0835
Study First Received: May 20, 2011
Results First Received: December 3, 2015
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration