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Effect of Ketamine (Ketalar) on Intracranial Pressure

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ClinicalTrials.gov Identifier: NCT00437814
Recruitment Status : Unknown
Verified February 2007 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : February 21, 2007
Last Update Posted : February 21, 2007
Sponsor:
Information provided by:
Rambam Health Care Campus

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 Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Drug: Ketamine, effect on intracranial pressure Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ketamine (Ketalar) on Intracranial Pressure
Study Start Date : September 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine




Primary Outcome Measures :
  1. Effect on intracranial pressure
  2. Effect on hemodynamic variables
  3. Effect on cerebral perfusion pressure


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437814


Contacts
Contact: Gad Bar-Joseph, MD 972-4-8542855 g_barjoseph@rambam.health.gov.il

Locations
Israel
Pediatric ICU, Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Gad Bar-Joseph, MD    972-4-8542855    g_barjoseph@rambam.health.gov.il   
Principal Investigator: Gad Bar-Joseph, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Gad Bar-Joseph, MD Director, Pediatric ICU, Rambam Medical Center

ClinicalTrials.gov Identifier: NCT00437814     History of Changes
Other Study ID Numbers: KETICP.CTIL
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007

Keywords provided by Rambam Health Care Campus:
Ketamine
Traumatic Brain Injury
Intracranial Hypertension

Additional relevant MeSH terms:
Hypertension
Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action