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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387556

Enrollment

268

Registered

2006-10-13

Start date

2002-12-31

Completion date

2006-12-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Keywords

ketamine, children, emesis

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.

Interventions

DRUGOndansetron

ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 21 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of vomiting	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

Secondary

Measure	Time frame	Description
Length of ED stay	Duration of ED stay	Secondary outcome measures were length of ED stay
Satisfaction with Sedation	Length of ED stay.	patient or parent satisfaction with their sedation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026