Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury|
- To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To compare the expression of biomarkers of CNS injury between cases and controls. [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Placebo Group receiving Saline Infusion.
1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
Case Group receiving Ketamine infusion.
1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)