Traumatic Brain InjuryNCT00437814
Effect of Ketamine (Ketalar) on Intracranial Pressure
A study testing Ketamine, effect on intracranial pressure in people with Traumatic Brain Injury and Intracranial Hypertension, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hypertension
- What is being tested?
- Ketamine, effect on intracranial pressure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric ICU, Rambam Medical Center
Haifa, 31096
Gad Bar-Joseph, MD, 972-4-8542855, g_barjoseph@rambam.health.gov.il
Gad Bar-Joseph, MD
About this study
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).
Read the 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.
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Being tested
- Ketamine, effect on intracranial pressure
- Keywords
- Ketamine, Traumatic Brain Injury, Intracranial Hypertension
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine, effect on intracranial pressureDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on intracranial pressure
Effect on hemodynamic variables
Effect on cerebral perfusion pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startSep 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Gad Bar-Joseph, MD, Study director, Director, Pediatric ICU, Rambam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437814
- Sponsor's protocol ID
- KETICP.CTIL
- Status last verified
- Feb 2007
- First submitted
- 19 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine (Ketalar) on Intracranial Pressure
- ClinicalTrials.gov ID
- NCT00437814
- Acronym / sponsor ID
- KETICP.CTIL
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Keywords
- Ketamine, Traumatic Brain Injury, Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Feb 2007
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine, effect on intracranial pressure | Drug | – |
Primary outcome
Effect on intracranial pressure
Effect on hemodynamic variables
Effect on cerebral perfusion pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Bar-Joseph, MD study director
Director, Pediatric ICU, Rambam Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, effect on intracranial pressure in people with Traumatic Brain Injury and Intracranial Hypertension, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gad Bar-Joseph, MD (972-4-8542855, g_barjoseph@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on intracranial pressure. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2007.