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

Study Overview
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Brief Summary
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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.

Official Title
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Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: saline
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo Group receiving Saline Infusion. | Drug: saline<br>* 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)<br>|
| Experimental: 2<br>Case Group receiving Ketamine infusion. | Drug: Ketamine<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the expression of biomarkers of CNS injury between cases and controls. |  | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury