Effect of Ketamine (Ketalar) on Intracranial Pressure

Study Overview
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Brief Summary
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Objectives: Ketamine is an effective, short-acting anesthetic drug, which does not decrease blood pressure. It is widely stated that Ketamine increases intracranial pressure (ICP), which prevents its use in many emergency situations, specifically in patients with traumatic brain injury (TBI) and with increased ICP. Based on previous clinical experience, we hypothesized that Ketamine decreases - rather than increases - ICP. Methods: Prospective, controlled, clinical trial. Children with ICP monitoring will receive a single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration (Before/after design).

Detailed Description
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Objectives: Ketamine is an effective, safe, rapid, short-acting anesthetic drug, and - contrary to all other anesthetic drugs - it does not decrease blood pressure. It is widely believed that Ketamine increases intracranial pressure (ICP), which prevents its use in many emergency situations, including trauma and specifically in patients with traumatic brain injury (TBI) and with increased ICP. Based on our previous clinical experience in patients with ICP monitoring, Ketamine did not increase ICP. We therefore hypothesize that Ketamine decreases - rather than increases - ICP. Methods: Prospective, controlled, clinical trial performed in a Pediatric ICU of a regional trauma center. Children with ICP monitoring receive a single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration (before/after study design). Parents/guardian of patients will be informed and asked to sign an informed consent.

Official Title
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Effect of Ketamine (Ketalar) on Intracranial Pressure

Conditions
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Traumatic Brain Injury, Intracranial Hypertension

Intervention / Treatment
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* Drug: Ketamine, effect on intracranial pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who have an ICP monitoring device, who either have increased ICP and/or who should undergo a potentially distressing activity (suction, position change etc.).
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketamine, effect on intracranial pressure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on intracranial pressure |  |  | 
| Effect on hemodynamic variables |  |  | 
| Effect on cerebral perfusion pressure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Traumatic Brain Injury, Intracranial Hypertension