Effect of Ketamine (Ketalar) on Intracranial Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00437814
First received: February 19, 2007
Last updated: February 20, 2007
Last verified: February 2007
  Purpose

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 Intervention
Traumatic Brain Injury
Intracranial Hypertension
Drug: Ketamine, effect on intracranial pressure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Ketamine (Ketalar) on Intracranial Pressure

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Effect on intracranial pressure
  • Effect on hemodynamic variables
  • Effect on cerebral perfusion pressure

Estimated Enrollment: 30
Study Start Date: September 2005
Estimated Study Completion Date: February 2007
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.

  Eligibility

Genders Eligible for Study:   Both
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00437814     History of Changes
Other Study ID Numbers: KETICP.CTIL
Study First Received: February 19, 2007
Last Updated: February 20, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014