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This study has been withdrawn prior to enrollment.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.)
Information provided by:
University of Arkansas
First received: November 9, 2007
Last updated: October 31, 2013
Last verified: October 2013
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.
Traumatic Brain Injury
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Placebo Comparator: 1
Placebo Group receiving Saline Infusion.
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)
Case Group receiving Ketamine infusion.
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)
|Ages Eligible for Study:
||1 Month to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
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
University of Arkansas
||Muayyad Tailounie, MD
||Arkansas Children's Hospital Research Institute
No publications provided
||Carole Hamon, Regulatory Affairs Manager, University of Arkansas for Medical Sciences
History of Changes
|Other Study ID Numbers:
||IRB 86674, 86674
|Study First Received:
||November 9, 2007
||October 31, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by University of Arkansas:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action