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Ondansetron Reduce Vomiting Associated With Ketamine PSA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00387556
First received: October 12, 2006
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

October 12, 2006
May 9, 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Length of ED stay [ Time Frame: Duration of ED stay ] [ Designated as safety issue: No ]
    Secondary outcome measures were length of ED stay
  • Satisfaction with Sedation [ Time Frame: Length of ED stay. ] [ Designated as safety issue: No ]
    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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
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.
Both
1 Year to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387556
02-0528
No
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