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

NCT ID: NCT00556387

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Placebo Group receiving Saline Infusion.

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

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)

2

Case Group receiving Ketamine infusion.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University of Arkansas for Medical Sciences

Principal Investigators

Muayyad Tailounie, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Countries

United States

Other Identifiers

86674

Identifier Type: -

Identifier Source: secondary_id

IRB 86674

Identifier Type: -

Identifier Source: org_study_id