MedTrace Logo

The Effects of the Anti Nausea Drugs Droperidol and Ondansetron on the Way the Heart Recovers Between Beats

NCT00624208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-09

No results posted yet for this study

Summary

We are investigating a new technique for testing the effect of drugs on electrical activity in the heart. Disturbances of this electrical activity can cause life-threatening changes to heart rhythms. A better way of measuring the risk has recently been developed, and our research team leads the world in using this tool to test the safety of drugs used in children. Children and their families want to know that the drugs being used are safe, as do the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60 children before and during their operations. The ECGs will then be checked by a children's heart specialist. Differences on the ECGs will be related to the presence and amount of drug (droperidol or ondansetron) given. We expect that the droperidol or ondansetron will not cause any changes that show increased risk of abnormal heart rhythms. We can then tell patients, parents and regulatory authorities of the safety profile of this aspect of the drug; moreover, the study can be used as a model for testing many other drugs used in hospitals.

Conditions

  • Myocardial Repolarization

Interventions

DRUG

droperidol and saline

droperidol 20 mcg.kg-1 and saline

DRUG

ondansetron and saline

ondansetron 0.1 mg.kg-1 and saline

DRUG

droperidol and ondansetron

droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1

DRUG

saline and saline

saline and saline

Sponsors & Collaborators

  • British Columbia Childrens Hospital Foundation

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Simon Whyte, MD · University of British Columbia

  • Mark Ansermino, MD · University of British Columbia

  • Shubhayan Sanatani, MD · University of British Columbia

  • Joanne Lim · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624208 on ClinicalTrials.gov