Ondansetron Reduce Vomiting Associated With Ketamine PSA

Conscious Sedation Clinical Trial

Official title:

Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387556
• Other study ID #: 02-0528
• Status: Completed
• Phase: N/A
• First received: October 12, 2006
• Last updated: May 9, 2013
• Start date: December 2002
• Est. completion date: December 2006

Study information

• Verified date: May 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Locations

Country	Name	City	State
United States	The Childrens Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of vomiting	The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up	Duration of ED stay and after discharge	No
Secondary	Length of ED stay	Secondary outcome measures were length of ED stay	Duration of ED stay	No
Secondary	Satisfaction with Sedation	patient or parent satisfaction with their sedation	Length of ED stay.	No