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

NCT00624208 | Completed

• 1 other identifier: H07-00615
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Randomized; double-blind; 4-group clinical interventional study

Outcome Measures

Primary Outcomes (1)

• Change in Tpeak-end interval before & after intervention & between groups.

  Before and during surgery

Secondary Outcomes (1)

• Change in QT intervals before & after intervention & between groups.

  Before and during surgery

Study Arms (4)

1

ACTIVE COMPARATOR

Intravenous injection of droperidol 20 mcg.kg-1 and saline (group 1)

Drug: droperidol and saline

2

ACTIVE COMPARATOR

Intravenous injection of ondansetron 0.1 mg.kg-1 and saline (group 2

Drug: ondansetron and saline

3

ACTIVE COMPARATOR

Intravenous injection of droperidol 20 mcg.kg-1 and ondansetron 0.1 mg.kg-1 (group 3)

Drug: droperidol and ondansetron

4

PLACEBO COMPARATOR

Intravenous injection of saline and saline (group 4)

Drug: saline and saline

Interventions

droperidol and saline DRUG

droperidol 20 mcg.kg-1 and saline

1

ondansetron and saline DRUG

ondansetron 0.1 mg.kg-1 and saline

2

droperidol and ondansetron DRUG

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

3

saline and saline DRUG

saline and saline

4

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Childrens Hospital Foundation: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Interventions

Droperidol; Sodium Chloride; Ondansetron

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Simon Whyte, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mark Ansermino, MD

  University of British Columbia

  STUDY DIRECTOR

• Shubhayan Sanatani, MD

  University of British Columbia

  STUDY DIRECTOR

• Joanne Lim

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

CA (1)