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

This study has been withdrawn prior to enrollment.
(This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00556387
First received: November 9, 2007
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: saline
Drug: Ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the expression of biomarkers of CNS injury between cases and controls. [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556387

Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Muayyad Tailounie, MD Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Carole Hamon, Regulatory Affairs Manager, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00556387     History of Changes
Other Study ID Numbers: IRB 86674, 86674
Study First Received: November 9, 2007
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Arkansas:
traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014