Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556387
Recruitment Status : Withdrawn (This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.)
First Posted : November 12, 2007
Last Update Posted : November 1, 2013
Information provided by:
University of Arkansas

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: saline Drug: Ketamine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
Study Start Date : December 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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)

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

Secondary Outcome Measures :
  1. To compare the expression of biomarkers of CNS injury between cases and controls. [ Time Frame: 96 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556387

Sponsors and Collaborators
University of Arkansas
Layout table for investigator information
Principal Investigator: Muayyad Tailounie, MD Arkansas Children's Hospital Research Institute

Layout table for additonal information
Responsible Party: Carole Hamon, Regulatory Affairs Manager, University of Arkansas for Medical Sciences Identifier: NCT00556387     History of Changes
Other Study ID Numbers: IRB 86674
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Keywords provided by University of Arkansas:
traumatic brain injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action