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Effect of Ketamine (Ketalar) on Intracranial Pressure

Primary Purpose

Traumatic Brain Injury, Intracranial Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Ketamine, effect on intracranial pressure

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Ketamine, Traumatic Brain Injury, Intracranial Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

Pediatric ICU, Rambam Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Effect on intracranial pressure

Effect on hemodynamic variables

Effect on cerebral perfusion pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00437814

First Posted

February 19, 2007

Last Updated

February 20, 2007

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT00437814

Brief Title

Effect of Ketamine (Ketalar) on Intracranial Pressure

Official Title

Effect of Ketamine (Ketalar) on Intracranial Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Intracranial Hypertension

Keywords

Ketamine, Traumatic Brain Injury, Intracranial Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ketamine, effect on intracranial pressure

Primary Outcome Measure Information:

Title

Effect on intracranial pressure

Title

Effect on hemodynamic variables

Title

Effect on cerebral perfusion pressure

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gad Bar-Joseph, MD

Phone

972-4-8542855

g_barjoseph@rambam.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gad Bar-Joseph, MD

Organizational Affiliation

Director, Pediatric ICU, Rambam Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Pediatric ICU, Rambam Medical Center

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gad Bar-Joseph, MD

Phone

972-4-8542855

g_barjoseph@rambam.health.gov.il

First Name & Middle Initial & Last Name & Degree

Gad Bar-Joseph, MD

12. IPD Sharing Statement

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Effect of Ketamine (Ketalar) on Intracranial Pressure

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