SUMMARY Etiology, clinical manifestations and outcome were reviewed in 139 cases of "iocked-ln syndrome." Six cases were reported from our center and the remaining 133 cases were taken from a review of the literature. The results of this review emphasized the necessity for a comprehensive program of pulmonary management in this population. Furthermore, an effective system of communication for the patient is considered essential hi the management of the "tocked-in" state. Reported mortality hi the cases reviewed was 60%. Overall, the prognosis for survival and recovery was found to be better hi the group of patients whose syndrome was nonvascular hi origin than those with a vascular etiology. Functional recovery was generally good in those patients with a vascular etiology who survived beyond 4 months while recovery occurred earlier and more completely hi the nonvascular group. Thus, a program of intensive rehabilitation should be considered early in both groups hi order to assist each patient hi attaining the highest level of function possible as recovery progresses.

Recommendations on use of interventional diagnostic tests and therapies, surgery, and interdisciplinary rehabilitation are presented. Due to important trade-offs between potential benefits, harms, costs, and burdens of alternative therapies, shared decision-making is an important component of a number of the recommendations.

Analgesic trials pose unique scientific, ethical, and practical challenges in pediatrics. Participants in a scientific workshop sponsored by the US Food and Drug Administration developed consensus on aspects of pediatric analgesic clinical trial design. The standard parallel-placebo analgesic trial design commonly used for adults has ethical and practical difficulties in pediatrics, due to the likelihood of subjects experiencing pain for extended periods of time. Immediate-rescue designs using opioid-sparing, rather than pain scores, as a primary outcome measure have been successfully used in pediatric analgesic efficacy trials. These designs maintain some of the scientific benefits of blinding, with some ethical and practical advantages over traditional designs. Preferred outcome measures were recommended for each age group. Acute pain trials are feasible for children undergoing surgery. Pharmacodynamic responses to opioids, local anesthetics, acetaminophen, and nonsteroidal antiinflammatory drugs appear substantially mature by age 2 years. There is currently no clear evidence for analgesic efficacy of acetaminophen or nonsteroidal antiinflammatory drugs in neonates or infants younger than 3 months of age. Small sample designs, including cross-over trials and N of 1 trials, for particular pediatric chronic pain conditions and for studies of pain and irritability in pediatric palliative care should be considered. Pediatric analgesic trials can be improved by using innovative study designs and outcome measures specific for children. Multicenter consortia will help to facilitate adequately powered pediatric analgesic trials.

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