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

Phase 2

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Drug: saline; Drug: Ketamine

• Registration Number: NCT00556387
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Start: 2008-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	saline	Placebo Group receiving Saline Infusion.
2	Ketamine	Case Group receiving Ketamine infusion.

Primary Outcome Measures

Name	Time	Method
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.	1 year

Secondary Outcome Measures

Name	Time	Method
To compare the expression of biomarkers of CNS injury between cases and controls.	96 hours