Ondansetron Reduce Vomiting Associated With Ketamine PSA

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

October 12, 2006
October 13, 2006
May 13, 2013
December 2002
December 2006   (Final data collection date for primary outcome measure)
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
incidence of vomiting
Complete list of historical versions of study NCT00387556 on Archive Site
  • 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
  • NPO status
  • adverse events
Not Provided
Not Provided
Ondansetron Reduce Vomiting Associated With Ketamine PSA
Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Conscious Sedation
Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Joe E Wathen, MD University of Colorado Health Science Center
University of Colorado, Denver
May 2013

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