Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
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|ClinicalTrials.gov Identifier: NCT00556387|
Recruitment Status : Withdrawn (This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.)
First Posted : November 12, 2007
Last Update Posted : November 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: saline Drug: Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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)
- To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. [ Time Frame: 1 year ]
- To compare the expression of biomarkers of CNS injury between cases and controls. [ Time Frame: 96 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556387
|Principal Investigator:||Muayyad Tailounie, MD||Arkansas Children's Hospital Research Institute|