Effect of Ketamine (Ketalar) on Intracranial Pressure
Brief 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).
Condition or Disease
- Traumatic Brain Injury
- Intracranial Hypertension
Phase
Study Design
| Study type: | Interventional |
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| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | Child, Adult, Older Adult |
| Enrollment: | 30 () |
| Funded by: | Other |
Masking |
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Clinical Trial Dates
| Start date: | Sep 05, 2020 | |
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| Primary Completion: | Aug 31, 2020 | |
| Completion Date: | Feb 07, 2020 | |
| Study First Posted: | Feb 21, 2007 | |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Feb 21, 2007 |
Sponsors / Collaborators
Location
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.
Eligibility Criteria
| Sex: | All |
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More Details
| NCT Number: | NCT00437814 |
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| Other IDs: | KETICP.CTIL |
| Study URL: | https://ClinicalTrials.gov/show/NCT00437814 |