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OpenTrials
Completed

NCT Number: NCT00387556

Ondansetron Reduce Vomiting Associated With Ketamine PSA

Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.

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Key information

Conditions

Conscious Sedation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Childrens Hospital

Denver, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

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

Other names: Zofran

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of ED stay

    Time frame: Duration of ED stay

    Secondary outcome measures were length of ED stay

  2. Satisfaction with Sedation

    Time frame: Length of ED stay.

    patient or parent satisfaction with their sedation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Oct 13, 2006
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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