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| ID | Type | Description | Link |
|---|---|---|---|
| 86674 |
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This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo Group receiving Saline Infusion. |
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| 2 | Experimental | Case Group receiving Ketamine infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline | Drug | 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) |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the expression of biomarkers of CNS injury between cases and controls. | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muayyad Tailounie, MD | Arkansas Children's Hospital Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Ketamine | Drug | 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) |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D017670 |
| Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |