Research needed on effects of anesthesia in infants and children

May 6, 2011

In an ongoing effort to establish clinical evidence for the effects of anesthesia and sedative agents on infants and children undergoing surgical, medical, or diagnostic procedures, the FDA?s Anesthetic and Life Support Drugs Advisory Committee recently convened a panel of experts to consider the available data, develop a research agenda, and discuss how to communicate risk/benefit information to clinicians and parents.

In an ongoing effort to establish clinical evidence for the effects of anesthesia and sedative agents on infants and children undergoing surgical, medical, or diagnostic procedures, the FDA’s Anesthetic and Life Support Drugs Advisory Committee recently convened a panel of experts to consider the available data, develop a research agenda, and discuss how to communicate risk/benefit information to clinicians and parents.

Numerous animal studies of the effects of anesthesia on the developing brains of juvenile rats and mice and in nonhuman primates have demonstrated harmful neurologic changes, and some researchers suggest that these findings could be extrapolated to young children. However, the committee reported that at this time there still is too little information to draw any conclusions about the effects of anesthesia and timing of administration on brain growth and cognition in children younger than 4 years, the corresponding age in humans.

Other retrospective and prospective epidemiology studies and clinical trials in children have limitations because of potential confounding issues or conflicting results, so causality between anesthesia or sedative agents and neurotoxicity in children cannot be clearly established on the basis of these studies, said the committee.

Because anesthetizing or sedating a child for a medical or surgical procedure rarely is optional, the committee emphasized the need for research studies that assess the outcomes after children are treated with anesthetics both in the short term and longer term in intensive care units. It suggested developing patient registries, defining cohorts based on anesthetic management technique, and initiating randomized controlled trials using these registries and cohorts.

The majority of committee members agreed that when parents inquire about anesthesia, clinicians should discuss with them the current state of knowledge, potential risks, and the uncertainty of clinical implications. Also, they should reassure parents that those who administer anesthesia or sedatives to children do their best to minimize exposure, duration, and concentration.