Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection

October 31, 2013 updated by: University of Arkansas

Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury

The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.

The researchers think that it will effect the outcomes of children with these injuries.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are 1 month to 16 years of age; AND
  • are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
  • are intubated and ventilated for the management of TBI; AND
  • are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
  • have an intra-cranial pressure (ICP) monitoring device for management of TBI.

Exclusion Criteria:

  • are less than 4 kilograms in weight upon admission
  • are less than 1 month of age;
  • are greater than 16 years of age;
  • have a clinical diagnosis of non-accidental TBI;
  • have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
  • have a known allergy to ketamine;
  • have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
  • have a current history of neuromuscular disease;
  • have a current history of hepatic failure;
  • have a current history of glaucoma
  • require chronic treatment with anti-epileptic drugs (AEDs) or devices;
  • more than 8 hours have elapsed from the time of injury to PICU admission;
  • have documentation of a positive pregnancy test at the time of enrollment;
  • if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo Group receiving Saline Infusion.
Drug: saline
1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
Experimental: 2
Case Group receiving Ketamine infusion.
Drug: Ketamine
1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the expression of biomarkers of CNS injury between cases and controls.
Time Frame: 96 hours
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Muayyad Tailounie, MD, Arkansas Children's Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 86674
  • 86674

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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