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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00556387
• Other study ID #: IRB 86674
• Secondary ID: 86674
• Status: Withdrawn
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: October 31, 2013
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 16 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.		1 year	No
Secondary	To compare the expression of biomarkers of CNS injury between cases and controls.		96 hours	No