Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Arkansas Children's Hospital Research Institute

Status and phase: Completed; Phase 2

Conditions: Ventricular Septal Defect

Treatments: Drug: saline; Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00556361

CUMG

28781 Bhutta

Details and patient eligibility

About

To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Enrollment: 24 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• less than one year of age
• undergoing cardiac surgery for repair of ventricular septal defect
• requiring cardiopulmonary bypass
• not requiring retrogrades cerebral perfusion

Exclusion criteria

• Downs Syndrome

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: saline

2

Experimental group

Treatment:

Drug: ketamine