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

University of Arkansas

Status and phase

Withdrawn

Phase 2

Conditions

Traumatic Brain Injury

Treatments

Drug: saline

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

86674

IRB 86674

Details and patient eligibility

About

The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.

The researchers think that it will effect the outcomes of children with these injuries.

Sex

All

Ages

1 month to 16 years old

Volunteers

No Healthy Volunteers

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).