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U.S. Department of Health and Human Services

About FDA

Pediatric Anesthetics

Description: Assessment of CNS toxicity caused by pediatric exposure to ketamine and other general anesthetics. This study is a collaborative effort with CDER.

Definition: Ketamine is primarily used for the induction and maintenance of general anesthesia, usually in combination with some sedative drugs. Ketamine is used in both human and veterinary medicine. These studies are working with three organisms having similar genomes to humans (zebra fish, rats, and monkeys) to provide information on ways to minimize risk associated with the pediatric use of general anesthetics.

Previous ketamine studies with monkeys have helped to identify developmental periods during which sensitivity to ketamine is greatest. The offspring of these animals will be used for further research on the effects of pediatric exposure to general anesthetics and will result in the development of translatable biomarkers for studying pediatric products.

Public Health Outcome: These studies will provide information on ways to minimize risk associated with the pediatric use of general anesthetics.

For more information on this research, watch the SmartTots video.

1. Cognitive Assessments of Laboratory Animals

This project was terminated due to an unacceptably high risk to laboratory animals.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Complete research on additional measures of cognitive function in laboratory animals exposed to ketamine

10/31/2010

Completed 10/31/2010

b. Complete assessment of research findings

1/1/2011

Completed 1/18/2011

c. Develop draft technical report/manuscript/publication on cognitive function in laboratory animal offspring exposed to ketamine

2/1/2011

Completed 2/10/2011

d. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

4/1/2011

Completed 4/1/2011

e. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

5/1/2011

Completed 5/1/2011

f. Submit final technical report, manuscript, and/or publication describing the cognitive assessments of laboratory animal offspring exposed to ketamine to a scientific journal

6/1/2011

Completed 6/1/2011

2. Ketamine Studies on Laboratory Animals

Accomplishment: NCTR investigators have demonstrated that a single 24-hour exposure to ketamine anesthesia during a sensitive period of brain development results in long-lasting deficits in brain function in nonhuman primates and provides proof-of-concept that general anesthesia administered to pediatric patients during critical periods of brain development could result in subsequent functional deficits. Nonhuman primates were exposed to ketamine for 24 hours on day 5 or 6 after birth and were tested for aspects of learning, motivation, color discrimination, and short-term memory using the NCTR Operant Test Battery (OTB) beginning at 7 months of age. At 10 months of age, the ketamine-exposed animals were significantly outperformed by the control animals. These treated animals, exposed to a single 24-hour exposure to anesthesia, continue to manifest cognitive impairments at over 3.5 years of age. These studies were supported by the National Institute of Child Health and Human Development (NICHD), the Center for Drug Evaluation and Research (CDER), and NCTR. A manuscript describing the results of this study has recently been accepted for publication in the journal Neurotoxicology and Teratology.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Furnish specialized animal laboratory

10/31/2009

Completed 12/31/2009

b. Approve all three protocols

1/31/2010

Completed 2/18/2010

c. Begin assessing ketamine’s effect on laboratory animal embryos

2/28/2010

Completed 2/19/2010

d. Assess ketamine's effect on cranial and spinal motor neurons

4/30/2010

Completed 4/25/2010

e. Effect of ketamine on neuronal signaling enzyme activity in laboratory animal

6/30/2010

Completed 6/16/2010

f. Determine neuronal levels of ketamine treated laboratory animals

8/31/2010

Completed 8/30/2010

g. Determine if ketamine affects neuronal gene expressions

8/31/2010

(1/30/2011)

Completed 12/31/2010

h. Complete research on effects of ketamine on laboratory animals

11/1/2010

Completed 11/1/2010

i. Completed assessment of research findings

11/15/2010

Completed 11/15/2010

j. Develop draft technical report/manuscript/publication on ketamine's effect on laboratory animals

11/30/2010

Completed 11/30/2011

k. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

2/1/2011

Completed 2/1/2011

l. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

3/1/2011

Completed 3/1/2011

m. Submit final technical report, manuscript, and/or publication on ketamine's effect on laboratory animal to a scientific journal

4/1/2011

Completed 4/1/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

CNS

Central Nervous System

ketamine

drug causing analgesic, anesthetic, elevated blood pressure and other effects in humans

cranial and spinal motor neurons

cells carrying electric signals coding for cognition sensation movement and other functions

neuronal

nerve cell that transmits impulses

enzyme

protein controlling biochemical reactions

neuronal gene expressions

the process by which a gene's coded information is converted into the structures operating in a cell

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.