The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

January 19, 2012 updated by: Do Kyun Kim, Seoul National University Hospital

The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children

The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Methods

  • a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
  • survey for the occurrence of vomiting at ED and after discharge

Primary outcome

  • the number of vomiting at ED and at home

Secondary outcome

  • parent's satisfaction and ED length of stay

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Do Kyun Kim, M.D.
          • Phone Number: 82-2-2072-0238
        • Principal Investigator:
          • Do Kyun Kim, M.D.
        • Sub-Investigator:
          • Jae Yun Jung, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children under 18 years of age
  • children who are planned to admit ketamine intramuscular injection
  • children with ASA classification class I or II

Exclusion Criteria:

  • don't want to enroll to study
  • children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
  • children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
  • children under 3 months of age
  • children whose weight are over 30 kg
  • children managed by other drug with ketamine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo group
Drug: Ondansetron
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Other Names:
  • Zofran zydis
  • vomiset
Experimental: Ondansetron
Ondansetron use group
Drug: Ondansetron
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Other Names:
  • Zofran zydis
  • vomiset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
vomiting at ED stay and 12 hours after discharge
Time Frame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge
the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
parent's satisfaction
Time Frame: satisfaction will be surveyed within 48hours after discharge
satisfaction will be surveyed within 48hours after discharge
length of emergency department stay
Time Frame: length of stay will be calculated upto 24 hours
length of stay will be calculated upto 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Asan Medical Center
Myongji Hospital

Investigators

  • Principal Investigator: Do Kyun Kim, M.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

October 23, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1105-114-364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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