The Emerging Therapeutic Role of Medical Foods for Gastrointestinal Disorders.

In addition to drugs approved by the US Food and Drug Administration (FDA) that treat, cure, or mitigate disease, medical foods are a tool to help manage chronic conditions and diseases. A medical food, according to the FDA, is a food that is developed to be eaten or administered enterally under the guidance of a physician and that is meant for the specific dietary management of a condition or disease for which distinctive nutritional requirements, based upon known scientific principles, are established by medical evaluation. A variety of medical foods exist to help manage a wide range of medical conditions, from Alzheimer disease to HIV-associated enteropathy. EnteraGam contains serum-derived bovine immunoglobulin/protein isolate, which has been studied extensively in diarrhea-predominant irritable bowel syndrome, inflammatory bowel disease (IBD), and HIV-associated enteropathy. VSL#3 is a probiotic that is used in pouchitis for patients with ulcerative colitis as well as irritable bowel syndrome. Modulen IBD is a whole-protein, sole-nutrition formulation used to manage the active phase of Crohn's disease. Vivonex is an elemental diet that is used in a variety of diseases associated with severe gastrointestinal dysfunction. Medical foods are safe and must have proven efficacy in helping to manage a variety of gastrointestinal conditions and diseases. These therapies represent tools that can be used prior or in addition to traditional medical therapies. This article discusses the history and development of medical foods under the FDA and concentrates specifically on medical foods used to help manage diseases of the gastrointestinal tract.

Reconstituted blood reduces blood donor exposures in children undergoing craniofacial reconstruction surgery.

OBJECTIVE/AIMS: To assess the effect of prophylactic administration of fresh-frozen plasma (FFP) in the form of reconstituted blood in children undergoing craniofacial reconstruction. The outcomes of interest included immediate postoperative coagulation laboratory test results, postoperative surgical drain output, and the number of unique blood donor exposures incurred. BACKGROUND: We recently changed our intraoperative transfusion strategy in children undergoing craniofacial reconstruction surgery to one in which blood loss is replaced with donor-matched reconstituted blood rather than traditional blood component therapy. METHODS: We performed a query of our prospective craniofacial surgery perioperative registry for children who underwent fronto-orbital advancement or posterior cranial vault reconstruction. Registry data from this query were compared to data from a historical cohort. RESULTS: Data for 46 registry cases were compared to 150 historical cohort cases. The median number of unique donor exposures for the reconstituted blood group was 2 vs 3 in the historical cohort (P=0.004). The reconstituted blood group had a decreased incidence of postoperative derangements in soluble clotting factor tests (fibrinogen, PT, or aPTT; 2% vs 24%, P=0.001), while there was no evidence for a difference in the incidence of thrombocytopenia. There was no evidence for differences in postoperative surgical drain output in the reconstituted blood group and historical cohort over the first 12, 24, and 48 h. CONCLUSIONS: Prophylactic administration of FFP in the form of donor-matched reconstituted blood in children undergoing craniofacial reconstruction was associated with improved postoperative coagulation parameters, reduced blood donor exposures, and unchanged postoperative surgical drain output.

Bradycardia during induction of anesthesia with sevoflurane in children with Down syndrome.

BACKGROUND: Bradycardia is a complication associated with inhaled induction of anesthesia with halothane in children with Down syndrome. Although bradycardia has been reported after anesthetic induction with sevoflurane in these children, the incidence is unknown. OBJECTIVES: In this study we compared the incidence and characteristics of bradycardia after induction of anesthesia with sevoflurane in children with Down syndrome to healthy controls. METHODS: We reviewed electronic anesthetic records of 209 children with Down syndrome and 268 healthy control patients who had inhaled induction of anesthesia with sevoflurane over an 8-year period. Data extracted from the medical record included demographics, history of congenital heart disease, heart rate, oxyhemoglobin saturation, expired sevoflurane concentrations, arterial blood pressure, and any treatment of bradycardia during the first 360 seconds after the start of induction of anesthesia. Bradycardia and hypotension were defined as heart rate and arterial blood pressure below the critical limits recommended for activating a pediatric rapid response team to the bedside of a hospitalized child for quick intervention. Factors associated with bradycardia were identified in a univariate analysis. A step-wise backward multiple logistic regression model was used to identify independent factors. Differences between the 2 groups were computed using Fisher's exact test or χ(2) tests for categorical data and t tests for continuous data. RESULTS: Univariate analysis demonstrated that Down syndrome, low ASA physical status, congenital heart disease, and mean sevoflurane concentrations were factors associated with bradycardia. However, multivariate analysis showed that only Down syndrome and low ASA physical status remained as independent factors associated with bradycardia. CONCLUSION: Bradycardia during anesthetic induction with sevoflurane was common in children with Down syndrome, with and without a history of congenital heart disease.

Overweight/obesity and gastric fluid characteristics in pediatric day surgery: implications for fasting guidelines and pulmonary aspiration risk.

BACKGROUND: The safety of 2-h preoperative clear liquid fasts has not been established for overweight/obese pediatric day surgical patients. Healthy children and obese adults who fasted 2 h have small residual gastric fluid volumes (GFVs), which are thought to reflect low pulmonary aspiration risk. We sought to measure the prevalence of overweight/obesity in our day surgery population. We hypothesized that neither body mass index (BMI) percentile nor fasting duration would significantly affect GFV or gastric fluid pH. In children who were allowed clear liquids up until 2 h before surgery, we hypothesized that overweight/obese subjects would not have increased GFV over lean/normal subjects and that emesis/pulmonary aspiration events would be rare. METHODS: Demographics, medical history, height, and weight were recorded for 1000 consecutive day surgery patients aged 2-12 yr. In addition, 1000 day surgery patients (age 2-12 yr) undergoing general endotracheal anesthesia were enrolled. After tracheal intubation, a 14-18F orogastric tube was inserted and gastric contents evacuated. Medications, fasting interval, GFV, pH, and emetic episodes were documented. Age- and gender-specific Center for Disease Control and Prevention growth charts (2000) were used to determine ideal body weight (IBW = 50th percentile) and to classify patients as lean/normal (BMI 25th-75th percentile), overweight (BMI > or = 85th to <95th percentile), or obese (BMI > or = 95th percentile). RESULTS: Of all day surgery patients, 14.0% were overweight and 13.3% were obese. Obese children had lower GFV per total body weight (P < 0.001). When corrected for IBW, however, volumes GFV(IBW) were identical across all BMI categories (mean 0.96 mL/kg, sd 0.71; median 0.86 mL/kg, IQR 0.96). Preoperative acetaminophen and midazolam contributed to increased GFV(IBW) (P = 0.025 and P = 0.001). Lower GFV(IBW) was associated with ASA physical status III (P = 0.024), male gender (P = 0.012), gastroesophageal reflux disease (P = 0.049), and proton pump inhibitor administration (P = 0.018). GFV(IBW) did not correlate with fasting duration or age. Decreased gastric fluid acidity was associated with younger age (P = 0.005), increased BMI percentile (P = 0.036), and African American race (P = 0.033). Emesis on induction occurred in eight patients (50% of whom were obese, P = 0.052, and 75% of whom had obstructive sleep apnea, P = 0.061). Emesis was associated with increased ASA physical status (P = 0.006) but not with fasting duration. There were no pulmonary aspiration events. CONCLUSIONS: Twenty-seven percent of pediatric day surgery patients are overweight/obese. These children may be allowed clear liquids 2 h before surgery as GFV(IBW) averages 1 mL/kg regardless of BMI and fasting interval. Rare emetic episodes were not associated with shortened fasting intervals in this population.