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Ondansetron Reduce Vomiting Associated With Ketamine PSA

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ClinicalTrials.gov Identifier: NCT00387556
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE October 12, 2006
First Posted Date  ICMJE October 13, 2006
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE December 2002
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
incidence of vomiting [ Time Frame: Duration of ED stay and after discharge ]
The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2006)
incidence of vomiting
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • Length of ED stay [ Time Frame: Duration of ED stay ]
    Secondary outcome measures were length of ED stay
  • Satisfaction with Sedation [ Time Frame: Length of ED stay. ]
    patient or parent satisfaction with their sedation
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2006)
  • NPO status
  • adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ondansetron Reduce Vomiting Associated With Ketamine PSA
Official Title  ICMJE Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Brief Summary Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Conscious Sedation
Intervention  ICMJE Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran
Study Arms  ICMJE
  • Experimental: Ketamine + Ondansetron
    ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
    Intervention: Drug: Ondansetron
  • Placebo Comparator: Ketamine + Placebo
    ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
    Intervention: Drug: Ondansetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2013)
268
Original Enrollment  ICMJE
 (submitted: October 12, 2006)
500
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion Criteria:

  • age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387556
Other Study ID Numbers  ICMJE 02-0528
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joe E Wathen, MD University of Colorado Health Science Center
PRS Account University of Colorado, Denver
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP