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

NCT00556387 | Withdrawn Phase 2

• 2 other identifiers: IRB 8667486674
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury.

  1 year

Secondary Outcomes (1)

• To compare the expression of biomarkers of CNS injury between cases and controls.

  96 hours

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo Group receiving Saline Infusion.

Drug: saline

2

EXPERIMENTAL

Case Group receiving Ketamine infusion.

Drug: Ketamine

Interventions

saline 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)

1

Ketamine 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)

2

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Sodium Chloride; Ketamine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Muayyad Tailounie, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 1, 2013

Record last verified: 2013-10