Effect of Ketamine (Ketalar) on Intracranial Pressure
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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 |
- 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 |
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 |
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| Contact: Gad Bar-Joseph, MD | 972-4-8542855 | g_barjoseph@rambam.health.gov.il |
| 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 | |
| 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:
|
Hypertension Intracranial Hypertension Brain Injuries Vascular Diseases Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Ketamine Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013