NCT00624208|Completed
The Effects of the Anti Nausea Drugs Droperidol and Ondansetron on the Way the Heart Recovers Between Beats
The Effects of Droperidol and Ondansetron on Dispersion of Myocardial Repolarization in Children
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The Effects of Droperidol and Ondansetron on Dispersion of Myocardial Repolarization in Children
Sponsor study identifier
interventional
80
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 18, 2008
Actual (reported)February 27, 2008
Actual (reported)August 2009
Actual (reported)August 2009
Actual (reported)Change in Tpeak-end interval before & after intervention & between groups.
Before and during surgery
Change in QT intervals before & after intervention & between groups.
Before and during surgery
Intravenous injection of droperidol 20 mcg.kg-1 and saline (group 1)
Intravenous injection of ondansetron 0.1 mg.kg-1 and saline (group 2
Intravenous injection of droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1 (group 3)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Partially structured registry wording
droperidol and saline
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
Partially structured registry wording
ondansetron and saline
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
Grouped treatment entry
droperidol and ondansetron
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
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
80 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2008
First Posted
February 27, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
Intravenous injection of saline and saline (group 4)
droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1
Linked from the registry description. Each source intervention is retained as reported.
In: droperidol and ondansetron
In: droperidol and ondansetron
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
November 9, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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