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

This study has been completed.
Sponsor:
Collaborator:
British Columbia Childrens Hospital Foundation
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00624208
First received: February 18, 2008
Last updated: August 17, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Repolarization
 Drug: droperidol and saline
Drug: ondansetron and saline
Drug: droperidol and ondansetron
Drug: saline and saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Droperidol and Ondansetron on Dispersion of Myocardial Repolarization in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in Tpeak-end interval before & after intervention & between groups. [ Time Frame: Before and during surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in QT intervals before & after intervention & between groups. [ Time Frame: Before and during surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous injection of droperidol 20 mcg.kg-1 and saline (group 1)
 Drug: droperidol and saline
droperidol 20 mcg.kg-1 and saline
Active Comparator: 2
Intravenous injection of ondansetron 0.1 mg.kg-1 and saline (group 2
 Drug: ondansetron and saline
ondansetron 0.1 mg.kg-1 and saline
Active Comparator: 3
Intravenous injection of droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1 (group 3)
 Drug: droperidol and ondansetron
droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1
Placebo Comparator: 4
Intravenous injection of saline and saline (group 4)
 Drug: saline and saline
saline and saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children (ASA I-II) undergoing procedures that require general anesthesia without pre-medication.

Exclusion Criteria:

  • Children with long QT syndrome, a family history of long QT syndrome or taking medication that is known to prolong the QT interval.
  • IV access unobtainable pre-operatively.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624208

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
British Columbia Childrens Hospital Foundation
Investigators
Principal Investigator: Simon Whyte, MD University of British Columbia
Study Director: Mark Ansermino, MD University of British Columbia
Study Director: Shubhayan Sanatani, MD University of British Columbia
Study Director: Joanne Lim University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Simon Whyte, University of British Columbia
ClinicalTrials.gov Identifier: NCT00624208     History of Changes
Other Study ID Numbers: H07-00615
Study First Received: February 18, 2008
Last Updated: August 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Randomized
double-blind
4-group clinical interventional study

Additional relevant MeSH terms:
Droperidol
Ondansetron
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 16, 2013