NCT00437814

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

February 19, 2007

Last Update Submit

February 20, 2007

Conditions

Traumatic Brain InjuryIntracranial Hypertension

Keywords

KetamineTraumatic Brain InjuryIntracranial Hypertension

Outcome Measures

Primary Outcomes (3)

  • Effect on intracranial pressure

  • Effect on hemodynamic variables

  • Effect on cerebral perfusion pressure

Interventions

Ketamine, effect on intracranial pressureDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric ICU, Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gad Bar-Joseph, MD

    Director, Pediatric ICU, Rambam Medical Center

    STUDY DIRECTOR

Central Study Contacts

Gad Bar-Joseph, MD

CONTACT

972-4-8542855g_barjoseph@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2007

First Posted

February 21, 2007

Study Start

September 1, 2005

Study Completion

February 1, 2007

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

IL(1)