Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection

Inclusion Criteria:

• are 1 month to 16 years of age; AND
• are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
• are intubated and ventilated for the management of TBI; AND
• are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
• have an intra-cranial pressure (ICP) monitoring device for management of TBI.

Exclusion Criteria:

• are less than 4 kilograms in weight upon admission
• are less than 1 month of age;
• are greater than 16 years of age;
• have a clinical diagnosis of non-accidental TBI;
• have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
• have a known allergy to ketamine;
• have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
• have a current history of neuromuscular disease;
• have a current history of hepatic failure;
• have a current history of glaucoma
• require chronic treatment with anti-epileptic drugs (AEDs) or devices;
• more than 8 hours have elapsed from the time of injury to PICU admission;
• have documentation of a positive pregnancy test at the time of enrollment;
• if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).