Clinical Trials Directory

Trials / Unknown

UnknownNCT00437814

Effect of Ketamine (Ketalar) on Intracranial Pressure

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (planned)
Sponsor
Rambam Health Care Campus · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGKetamine, effect on intracranial pressure

Timeline

Start date
2005-09-01
Completion
2007-02-01
First posted
2007-02-21
Last updated
2007-02-21

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00437814. Inclusion in this directory is not an endorsement.