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OBJECTIVES: Leftover prescription opioids pose risks to children and adolescents, yet many parents keep these medications in the home. Our objective in this study was to determine if providing a behavioral disposal method (ie, Nudge) with or without a Scenario-Tailored Opioid Messaging Program (STOMP) (risk-enhancement education) improves parents’ opioid-disposal behavior after their children’s use. METHODS: Parents whose children were prescribed a short course of opioids were recruited and randomly assigned to the Nudge or control groups with or without STOMP. Parents completed surveys at baseline and 7 and 14 days. Main outcomes were (1) prompt disposal (ie, immediate disposal of leftovers after use) and (2) planned retention (intention to keep leftovers). RESULTS: There were 517 parents who took part, and 93% had leftovers after use. Prompt disposal behavior was higher for parents who received both the STOMP and Nudge interventions (38.5%), Nudge alone (33.3%), or STOMP alone (31%) compared with controls (19.2%; P ≤ .02). Furthermore, the STOMP intervention independently decreased planned retention rates (5.6% vs 12.5% no STOMP; adjusted odds ratio [aOR] 0.40 [95% confidence interval (CI) 0.19–0.85]). Higher risk perception lowered the odds of planned retention (aOR 0.87 [95% CI 0.79–0.96]), whereas parental past opioid misuse increased those odds (aOR 4.44 [95% CI 1.67–11.79]). CONCLUSIONS: Providing a disposal method nudged parents to dispose of their children’s leftover opioids promptly after use, whereas STOMP boosted prompt disposal and reduced planned retention. Such strategies can reduce the presence of risky leftover medications in the home and decrease the risks posed to children and adolescents.

OBJECTIVES: Overweight in children is most commonly described by using BMI. Because BMI does not adequately describe regional (central) adiposity, other indices of body fatness are being explored. Neck circumference (NC) is positively associated with obstructive sleep apnea, diabetes, and hypertension in adults. NC also has positive correlation with BMI in adults. The possible role of NC in screening for high BMI in children is not well characterized. The aims of this investigation were to examine the correlation between BMI and NC in children and to determine the best NC cutoff that identifies children with high BMI. METHODS: Children who were aged 6 to 18 years and undergoing elective noncardiac surgeries were the subjects of this study. Trained research assistants collected clinical and anthropometric data from all patients. We calculated Pearson correlation coefficients between NC and other indices of obesity. We then determined by receiver operating characteristic analyses the optimal NC cutoff for identifying children with high BMI. RESULTS: Among 1102 children, 52% were male. NC was significantly correlated with age, BMI, and waist circumference in both boys and girls, although the correlation was stronger in older children. Optimal NC cutoff indicative of high BMI in boys ranged from 28.5 to 39.0 cm. Corresponding values in girls ranged from 27.0 to 34.6 cm. CONCLUSIONS: NC is significantly correlated with indices of adiposity and can reliably identify children with high BMI. NC is a simple technique that has good interrater reliability and could be used to screen for overweight and obesity in children.

OBJECTIVES:Informed decision-making requires that parents and research subjects understand the risks and benefits of a study, yet research suggests that comprehension of these elements is often poor. This study was designed to examine the effect of factors including manipulation of risk/benefit trade-offs, numeracy, and sociodemographics on parents’ understanding of risks and benefits.METHODS:A total of 4685 parents completed an Internet survey in which they were randomly assigned to receive information about the risks and benefits of a hypothetical pain treatment study presented in 1 of 4 scenarios. Parents’ gist (essential) and verbatim (exact) understanding and their perceptions of the risks and benefits were compared across scenarios. The effects of parental sociodemographics and numeracy were also examined.RESULTS:Participants who were randomly assigned to consider a research study that offered the possibility of improved outcomes had higher gist and verbatim understanding of the information than participants who were considering studies that offered only reductions in the risk for adverse effects. Furthermore, these parents perceived the risks of the study to be significantly lower compared with the scenarios that offered the same risks but less benefit. White race, college education, and higher numeracy all were associated significantly with improved gist and verbatim understanding.CONCLUSIONS:Research studies that offer only improved outcomes to participants may be evaluated more thoroughly than those that offer only reduced risks, and individual characteristics significantly moderate parents’ ability to comprehend risk/benefit information. These results are important toward developing strategies to improve the ways in which risks and benefits are communicated to parents and research subjects.

OBJECTIVE. This study evaluated age- and sedative agent–related differences in bispectral index across observed sedation levels in a large sample of children PATIENTS AND METHODS. With institutional review board approval and waiver of consent, data from 4 independently conducted studies were combined in a secondary analysis of 3373 observations from 248 children aged 1 month to 18 years. In these studies, bispectral index values of sedated children were recorded in a blinded fashion, and sedation depth was scored using the University of Michigan Sedation Scale (UMSS). Bispectral index was evaluated across UMSS scores for several age groups and during use of each sedative agent (with/without opioids). RESULTS. There was a moderate inverse correlation between bispectral index and UMSS for all age groups. There were significant differences in bispectral index across UMSS and between each sedation level except UMSS 3 to 4 in all the age groups and UMSS 0 to 1 in infants. The mean bispectral index and the cutoff values on the receiver-operating-characteristic curve for mild, moderate, and deep sedation were significantly lower in infants ≤6 months compared with older children at each sedation level. Bispectral index was reasonably sensitive and specific in differentiating mild (UMSS 0–1) from deeper (UMSS 3–4) levels of sedation but poorly differentiated between moderate and deep levels of sedation in all age groups. There was a moderate correlation between bispectral index and UMSS during the use of chloral hydrate, pentobarbital, propofol, and midazolam but poor correlation during ketamine or opioid use. Bispectral index values were significantly lower during deep sedation with propofol and pentobarbital compared with midazolam and chloral hydrate. CONCLUSIONS. Our findings suggest that, although bispectral index may differentiate light from deep sedation in most children, bispectral index must be interpreted cautiously in sedated children, with particular consideration given to patient age and use of sedative agents.

Objective. The ability to assess accurately the risks and benefits of a study are important to ensure that the subject can make an informed decision regarding his or her own or his or her surrogate’s participation. This study was designed to examine factors that influence parents’ assessments of the risks and benefits of anesthesia and surgery research involving their children. Methods. The study population consisted of parents of 505 children who had been approached to participate in 1 of several ongoing clinical studies. Regardless of their decision to allow or decline their child’s participation in a study, parents completed a questionnaire that elicited information regarding their perceptions of the risks and benefits of the study and factors that had influenced their decision. Results. Factors that influenced positive risk/benefit assessments by the parents included use of a placebo, the designated risk category of the study, the clarity of information given, the parents’ perceptions of the amount of time provided to make a decision, and the amount of privacy afforded them in making a decision. Furthermore, positive risk/benefit assessments were associated with low decisional uncertainty and greater trust in the medical system. Conclusions. Identification of factors that influence parents’ perceptions of the risks and benefits of a research study is important as a means to optimize the manner in which consent information is disclosed and to ensure that parents and subjects can assess accurately the relative importance of the risks and benefits.

Objective.Although sedation-related adverse events in children in the hospital setting have been extensively reported, limited data are available regarding adverse events after discharge home. Despite nationally recommended discharge criteria, in busy outpatient settings, children may be sent home into the care of their parents after a brief recovery from sedation, placing them at risk for adverse events in an unmonitored setting. Previous studies have not addressed issues such as requirement for escalation of care after discharge (ie, emergency department visits or hospitalization), or parental satisfaction with their child's sedation experience. This study was undertaken to evaluate the recovery and delayed adverse events after discharge of children who received sedation for magnetic resonance imaging or computed tomography.Methods. With approval from the institutional review board and written informed consent from a parent, children (Results. Three hundred seventy six children comprised the sample. Eighty nine percent of children received chloral hydrate (CH; 64 ± 13 mg/kg), and 11% midazolam (.15 ± .13 mg/kg) as the primary sedative. There was an 8% incidence of failed sedation, and a 1.6% incidence of hypoxemia during the procedure. Three children required prolonged monitoring in the postanesthesia care unit before discharge; 1 child attributable to an allergic reaction, a second attributable to wheezing and oxygen desaturation, and the third attributable to prolonged sedation from CH and midazolam. These children were discharged home from the postanesthesia care unit without additional sequelae.Side effects after discharge included: motor imbalance (31%), gastrointestinal effects (23%), agitation (19%), and restlessness (14%). Agitation and restlessness lasted greater than 6 hours in more than one third of children who experienced these effects. CH was more commonly associated with imbalance compared with midazolam, and restlessness and prolonged imbalance were associated with younger age. Medical advice was sought after discharge for 15 (4%) children, 3 of whom required a visit to the emergency department for excessive or prolonged sedation. Each of these children had received CH as a sole sedative in recommended doses (61–77 mg/kg). In 1 of these cases, the procedure had been aborted because of inadequate sedation in the hospital, yet the child became difficult to arouse at home.Only 48% of children returned to baseline activity and behavior within 8 hours of the procedure; however, 89% were back to baseline status within 24 hours. Notably, 5% of all children did not return to baseline activity until the second day after the procedure. Although not statistically significant, infants Conclusions. Our data demonstrate that children may experience prolonged recovery as well as a significant incidence of delayed side effects after sedation for a diagnostic procedure. Specifically, we found a high incidence of motor imbalance, agitation, gastrointestinal effects, and restlessness after discharge. Factors related to these side effects included younger age (restlessness and prolonged imbalance) and use of CH (agitation and motor imbalance). Failed sedation and agitation contributed significantly to parental dissatisfaction with the child's sedation experience. These findings highlight the importance of careful presedation education and preparation of the patient/family regarding the potential for delayed recovery, anticipated side effects, and how to obtain medical follow-up if necessary. Future studies should focus on sedation methods that reduce sedation-related adverse events and promote the safety of sedated children.

To the Editor. The vitriolic comments by Drs Freeman and Vining regarding various sedation/analgesia guidelines and Dr Cote's critical incident analysis of sedation-related adverse events underscore the need for the utilization of evidence in the evaluation of the safety of such practices.1 ,2 Drs Freeman and Vining contend that sedation alone for a nonpainful procedure such as an electroencephalogram (EEG) is inherently safe. They therefore suggest that the use of chloral hydrate alone for an EEG does not warrant any monitoring or attendance by qualified medical personnel as mandated by the Joint Commission on Accreditation of Healthcare Organizations and recommended by the American Academy of Pediatrics. Furthermore, they contend that such mandates are unnecessary and fiscally onerous. The evidence does not support their contention. We agree that the majority of children who receive sedation, analgesia, or both for a diagnostic or therapeutic procedure experience good outcomes with no long-term sequelae. However, the fortunately low incidence of adverse events should not lead to the conclusion that such guidelines are unnecessary. In fact, contrary to the conclusion of Drs Freeman and Vining, the literature is replete with reports of sedation-related adverse events.2–8 We would direct Drs Freeman and Vining to several large, well-conducted, prospective studies that have not only addressed the incidence of adverse events with chloral hydrate sedation but have also provided a denominator.3–8 These studies are not anecdotal, have appropriate statistical analysis, and include patients who had adverse events after the administration of chloral hydrate alone, without other sedative or analgesic agents. Indeed, it is reports such as these that have led to the development of monitoring guidelines and personnel mandates to promote the safety of sedated children. Although chloral hydrate in therapeutic doses is purported not to cause significant respiratory depression, it may still cause respiratory …