NCT00387556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

Enrollment Period

4 years

First QC Date

October 12, 2006

Last Update Submit

May 9, 2013

Conditions

Conscious Sedation

Keywords

ketaminechildrenemesis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Length of ED stay

    Duration of ED stay

  • Satisfaction with Sedation

    Length of ED stay.

Study Arms (2)

Ketamine + Ondansetron

EXPERIMENTAL

ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Drug: Ondansetron

Ketamine + Placebo

PLACEBO COMPARATOR

ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo

Drug: Ondansetron

Interventions

OndansetronDRUG

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

Also known as: Zofran
Ketamine + OndansetronKetamine + Placebo

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 1-21 years, ASA I or II, fracture of dislocation reduction

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Childrens Hospital

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Joe E Wathen, MD

    University of Colorado Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

December 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 13, 2013

Record last verified: 2013-05

Locations

US(1)