Endoscopic Versus Open Repair for Craniosynostosis in Infants Using Propensity Score Matching to Compare Outcomes: A Multicenter Study from the Pediatric Craniofacial Collaborative Group.

BACKGROUND: The North American Pediatric Craniofacial Collaborative Group (PCCG) established the Pediatric Craniofacial Surgery Perioperative Registry to evaluate outcomes in infants and children undergoing craniosynostosis repair. The goal of this multicenter study was to utilize this registry to assess differences in blood utilization, intensive care unit (ICU) utilization, duration of hospitalization, and perioperative complications between endoscopic-assisted (ESC) and open repair in infants with craniosynostosis. We hypothesized that advantages of ESC from single-center studies would be validated based on combined data from a large multicenter registry. METHODS: Thirty-one institutions contributed data from June 2012 to September 2015. We analyzed 1382 infants younger than 12 months undergoing open (anterior and/or posterior cranial vault reconstruction, modified-Pi procedure, or strip craniectomy) or endoscopic craniectomy. The primary outcomes included transfusion data, ICU utilization, hospital length of stay, and perioperative complications; secondary outcomes included anesthesia and surgical duration. Comparison of unmatched groups (ESC: N = 311, open repair: N = 1071) and propensity score 2:1 matched groups (ESC: N = 311, open repair: N = 622) were performed by conditional logistic regression analysis. RESULTS: Imbalances in baseline age and weight are inherent due to surgical selection criteria for ESC. Quality of propensity score matching in balancing age and weight between ESC and open groups was assessed by quintiles of the propensity scores. Analysis of matched groups confirmed significantly reduced utilization of blood (26% vs 81%, P < .001) and coagulation (3% vs 16%, P < .001) products in the ESC group compared to the open group. Median blood donor exposure (0 vs 1), anesthesia (168 vs 248 minutes) and surgical duration (70 vs 130 minutes), days in ICU (0 vs 2), and hospital length of stay (2 vs 4) were all significantly lower in the ESC group (all P < .001). Median volume of red blood cell administered was significantly lower in ESC (19.6 vs 26.9 mL/kg, P = .035), with a difference of approximately 7 mL/kg less for the ESC (95% confidence interval for the difference, 3-12 mL/kg), whereas the median volume of coagulation products was not significantly different between the 2 groups (21.2 vs 24.6 mL/kg, P = .73). Incidence of complications including hypotension requiring treatment with vasoactive agents (3% vs 4%), venous air embolism (1%), and hypothermia, defined as <35°C (22% vs 26%), was similar between the 2 groups, whereas postoperative intubation was significantly higher in the open group (2% vs 10%, P < .001). CONCLUSIONS: This multicenter study of ESC versus open craniosynostosis repair represents the largest comparison to date. It demonstrates striking advantages of ESC for young infants that may result in improved clinical outcomes, as well as increased safety.

Perioperative Outcomes and Management in Pediatric Complex Cranial Vault Reconstruction: A Multicenter Study from the Pediatric Craniofacial Collaborative Group.

BACKGROUND: The Pediatric Craniofacial Collaborative Group established the Pediatric Craniofacial Surgery Perioperative Registry to elucidate practices and outcomes in children with craniosynostosis undergoing complex cranial vault reconstruction and inform quality improvement efforts. The aim of this study is to determine perioperative management, outcomes, and complications in children undergoing complex cranial vault reconstruction across North America and to delineate salient features of current practices. METHODS: Thirty-one institutions contributed data from June 2012 to September 2015. Data extracted included demographics, perioperative management, length of stay, laboratory results, and blood management techniques employed. Complications and outlier events were described. Outcomes analyzed included total blood donor exposures, intraoperative and perioperative transfusion volumes, and length of stay outcomes. RESULTS: One thousand two hundred twenty-three cases were analyzed: 935 children aged less than or equal to 24 months and 288 children aged more than 24 months. Ninety-five percent of children aged less than or equal to 24 months and 79% of children aged more than 24 months received at least one transfusion. There were no deaths. Notable complications included cardiac arrest, postoperative seizures, unplanned postoperative mechanical ventilation, large-volume transfusion, and unplanned second surgeries. Utilization of blood conservation techniques was highly variable. CONCLUSIONS: The authors present a comprehensive description of perioperative management, outcomes, and complications from a large group of North American children undergoing complex cranial vault reconstruction. Transfusion remains the rule for the vast majority of patients. The occurrence of numerous significant complications together with large variability in perioperative management and outcomes suggest targets for improvement.

The incidence of intraoperative awareness in children: childhood awareness and recall evaluation.

BACKGROUND: There is a considerable discrepancy between the reported incidences of awareness under anesthesia in children (0.2%-2.7%). In this prospective, observational, cohort study we evaluated 1) the incidence of awareness during general anesthesia in children across three settings, 2) factors contributing to awareness, and 3) short-term psychological effects of awareness. METHODS: Children (aged 5-15 yr) who underwent general anesthesia were included, and all perioperative data including anesthetic drugs were collected prospectively. Children were interviewed three times postoperatively using a semistructured questionnaire. All cases of possible or probable awareness were discussed with the child's care providers to confirm or refute the memories. Internal consensus among investigators across sites was reached, and these cases and a random selection of others were reviewed by three external reviewers. For the purpose of this study, possible/probable awareness was defined as cases with agreement between the internal consensus and at least two of the three external reviewers. RESULTS: One thousand seven hundred eighty-four children completed at least one interview. Thirty-two cases were coded as possible or probable awareness by at least one entity (i.e., either the internal consensus or one of the external reviewers). Fourteen of these cases met the definition for possible/probable awareness, making the incidence of awareness 0.8%. Six of the 14 children with awareness (43%) remembered feeling scared during their surgery and three (21%) reported hurting. Two children in this group (14%) said they would feel worse if they had to have surgery again, which was not significantly different from reports of children with no recall (15%). None of the children with awareness required psychological follow-up. Endoscopic procedures were associated with a higher risk for awareness (relative risk = 4.5 [confidence interval 1.5-13.6]). CONCLUSIONS: Although 0.8% of children experienced possible/probable awareness in this study, none experienced short-term psychological distress.

The effect of insufflation pressure on pulmonary mechanics in infants during laparoscopic surgical procedures.

BACKGROUND: Few studies have reported objective measurements of pulmonary changes under controlled conditions in infants undergoing laparoscopic procedures. We objectively measured the pulmonary effects of laparoscopically-induced pneumoperitoneum in infants less than 1 year of age undergoing surgical procedures under general anaesthesia. METHODS: Nineteen ASA I-II patients less than 1 year of age were enrolled in this direct observational study. Anaesthetic technique included inhalation induction using sevoflurane/O2/air and neuromuscular blockade. Infants were ventilated using 10-15 ml.kg-1 tidal volume at a respiratory rate sufficient to achieve normocarbia [PECO2 4.6-5.8 kPa (35-45 mmHg)]. Opioids and regional anaesthesia techniques were used when appropriate. Peak inspiratory pressure (PIP), expiratory tidal volume (Vt), endtidal carbon dioxide concentration (PECO2) and dynamic compliance (COMPdyn) were recorded at baseline, 5, 10 mmHg and maximal insufflation pressure (Pmax). Pmax was limited to 12 mmHg for infants <5 kg, 15 mmHg for infants >5 kg. At steady state Pmax, ventilator changes were implemented to restore Vt and PECO2 to within 10% of baseline. Each patient served as his own control. RESULTS: At Pmax, average PIP increased 18%, average Vt decreased 33%, average PECO2 concentration increased 13%, average COMPdyn decreased 48%; O2 saturation fell in 41% of patients. Twenty ventilator adjustments were required; one patient experienced no changes in measured pulmonary mechanics, requiring no ventilator changes. CONCLUSIONS: Pulmonary mechanics in infants change significantly during laparoscopic CO2 pneumoperitoneum; the magnitude of change correlates directly with intraperitoneal pressure. Greater than 90% of infants required at least one ventilatory intervention to restore baseline Vt and PECO2.

Midazolam premedication in children: a comparison of two oral dosage formulations on sedation score and plasma midazolam levels.

We compared two available oral formulations of midazolam with respect to sedation score and plasma midazolam levels in pediatric surgical patients 2-10 yr old. The commercially available oral syrup was compared with a mixture of the IV midazolam preparation in Syrpalta syrup at an equivalent concentration of 2 mg/mL. ASA status I-II patients were randomly assigned to receive 0.5 mg/kg of either the commercial syrup (Group 1) or the prepared mixture (Group 2) as anesthetic premedication. Observer's Assessment of Alertness/Sedation scores were obtained by a blinded observer at 15 and 30 min after drug administration. Plasma midazolam levels were acquired exactly 45, 60, and 90 min after administration. Group 2 patients had a significantly lower median Observer's Assessment of Alertness/Sedation score (Group 1, 17; Group 2, 15) at 30 min (P < 0.03) and significantly higher mean plasma midazolam levels at all three acquisition times (mean +/- SD) (45 min: 63.1 +/- 23.9 ng/mL, Group 2; 43.4 +/- 19.6 ng/mL, Group 1; 60 min: 45.8 +/- 18.2 ng/mL, Group 2; 30.8 +/- 17.9 ng/mL, Group 1; 90 min: 28.9 +/- 12.6 ng/mL, Group 2; 21.0 +/- 8.9 ng/mL, Group 1) (P < 0.02). We conclude that IV midazolam mixed in Syrpalta syrup yields more reliable sedation and correspondingly higher plasma levels than an equivalent dose of the commercially formulated and marketed preparation.

Oral midazolam premedication in preadolescents and adolescents.

UNLABELLED: We sought to determine the influence of preoperative oral midazolam on 1) sedation score, 2) measures of anesthetic emergence, 3) recovery times, and 4) bispectral index (BIS) measurements during sevoflurane/N(2)O anesthesia in adolescent patients. Fifty ASA I and II patients 10-18 yr of age were enrolled in a prospective double-blinded study. Patients were randomized to receive either 20 mg of midazolam (M group) or midazolam vehicle (P group) as premedication. Before the induction, sedation scores and BIS values were determined in all patients. After inhaled induction and intubation, expired sevoflurane was stabilized at 3% in 60% N(2)O and the corresponding BIS (BIS I) recorded. Upon completion of surgery, sevoflurane was stabilized at 0.5% and the BIS (BIS E) again recorded. Plasma midazolam levels were measured at the time of BIS I and BIS E. There were no significant differences between groups in awakening time, sevoflurane/N(2)O awakening concentrations, time to postanesthesia care unit discharge, or BIS I and BIS E measurements. Sedation scores and preinduction BIS values were significantly lower in Group M than in Group P, although only 40% of midazolam-treated patients exhibited detectable sedation, with marked interindividual variability in achieved plasma midazolam levels. Detectable preoperative sedation was predictive of delayed emergence. IMPLICATIONS: We demonstrated a measurable sedative effect of oral midazolam in adolescents which correlated with simultaneous bispectral index (BIS) measurement. Considering the overall group, midazolam premedication did not affect intraoperative BIS, emergence times, or recovery times compared with placebo controls. Detectable preoperative sedation, and not merely midazolam administration, was predictive of prolonged emergence.