Efficacy Outcome Measures for Pediatric Procedural Sedation Clinical Trials: An ACTTION Systematic Review.

Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Update on pharmacological management of procedural sedation for children.

PURPOSE OF REVIEW: The review provides an update on pharmacological techniques for procedural sedation for children outside the operating room. RECENT FINDINGS: An increasing number of studies of propofol, ketamine, nitrous oxide, dexmedetomidine, and intranasal administration of drugs for procedural sedation of children continue to be reported. SUMMARY: Propofol and ketamine are commonly used for procedural sedation in children and the use of dexmedetomidine and nitrous oxide is increasing. Although the intravenous route remains the mainstay; intranasal drug administration is increasingly used for anxiolysis and moderate sedation.

Variation in Procedural Sedation Practices Among Children's Hospitals.

BACKGROUND AND OBJECTIVE: Children often need procedural sedation for painful procedures. There are few data on type of provider, site of sedation, and agents used for procedural sedation in hospitals across the nation. The objective was to determine procedural sedation practices for hospitalized children outside the PICU and emergency department. METHODS: Surveys were sent to 89 pediatric hospitalist (PH) leaders in hospitals belonging to the Child Health Corporation of America or the National Association of Children's Hospitals and Related Institutions. RESULTS: We received responses from 56 PHs (63%), of whom 49 (55%) completed the survey. PHs provided sedation in 18 hospitals. Provider, setting, and agents used for procedural sedation varied. The primary providers of procedural sedation for abscess incision and drainage, renal biopsy, joint aspiration, computed tomography, and MRI were anesthesiologists. A significantly greater percentage of hospitals where PHs did not provide procedural sedation used the operating room for abscess incision and drainage compared with hospitals where PHs provided procedural sedation (63% vs 28%, respectively). Postoperative/abscess dressing change, vesicocystourethrogram, and ≥1 painful procedure were performed without sedation in significantly greater percentage of hospitals where PHs did not provide procedural sedation compared with hospitals where PHs provided procedural sedation. CONCLUSIONS: There is variability in sedation practices in hospitals across the nation, which affects patient care and use of resources such as the operating room. In hospitals where PHs provide procedural sedation, there is less operating room use and fewer painful procedures for which no sedation is provided.

Pediatric sedation.

Pediatric sedation is an evolving field performed by an extensive list of specialties. Well-defined sedation systems within pediatric facilities are paramount to providing consistent, safe sedation. Pediatric sedation providers should be trained in the principles and practice of sedation, which include patient selection, pre-sedation assessment to determine risks during sedation, selection of optimal sedation medication, monitoring requirements, and post-sedation care. Training, credentialing, and continuing sedation education must be incorporated into sedation systems to verify and monitor the practice of safe sedation. Pediatric hospitalists represent a group of providers with extensive pediatric knowledge and skills who can safely provide pediatric sedation.

Successful implementation of a referral-based academic pediatric hospitalist service.

OBJECTIVE: St Louis Children's Hospital (SLCH) developed Service for Hospital Admissions by Referring Physicians (SHARP) in January 2008 as an inpatient referral service for pediatricians who previously admitted their own patients. We hypothesized that use of SHARP would make hospitalization more efficient and cost-effective compared with the general pediatric medicine (GM) service. METHODS: Admission volumes, diagnoses, length of stay (LOS), costs, and physician billing data were abstracted from SLCH information systems and the Pediatric Health Information System database. We compared admissions for SHARP and GM from January 2008 through June 2010. RESULTS: SHARP had lower LOS and costs versus GM, with no change in 7-day readmission rate. Median LOS was 2 days for SHARP and 3 days for GM (P<.001). Median hospital cost per patient was $2719 for SHARP and $3062 for GM (P<.001). Over the study period, the admission rate increased 37% and daily patient encounters increased 39%. Physician billing revenue increased 25% in the first 6 months, then continued to increase steadily. Total physicians and geographic referral area using SHARP increased, and referring physician satisfaction was high. CONCLUSIONS: SHARP approaches financial independence and provides a cost savings to SLCH. LOS decreased by a statistically significant amount compared with GM with no change in readmission rate. Referring physician satisfaction was high, likely allowing for growth in referrals to SLCH. SHARP hospitalists' collaboration with referring physicians, ensuring excellent follow-up, provides decreased duration of hospitalization and resource utilization. Our availability throughout the day to reassess patients increases efficiency. We project that we must average 12.6 daily encounters to be financially independent.

Procedural sedation by pediatric hospitalists: analysis of the nature and incidence of complications during ketamine and nitrous oxide sedation.

OBJECTIVE: The goal of this study was to determine the nature and rate of complications during procedural sedation by pediatric hospitalists (PH) using ketamine and nitrous oxide (N2O). METHODS: This study was a retrospective review and analysis of a quality improvement database for sedations performed by PH at St Louis Children's Hospital from February 2007 to February 2013. Information was obtained on sedations performed and reported in the quality improvement database by PH over this time period using ketamine and N2O. RESULTS: PH performed 8870 sedations from 2007 to 2013, 60.2% using ketamine and 39.8% using N2O. Procedural completion rates were >99%; 0.12% of sedations were not completed due to inadequate sedation, and sedation level was not achieved in 1.71% of sedations. There were no occurrences of death, need for cardiopulmonary resuscitation, unplanned intubation, or emergency anesthesia consultation. The only major complications were 4 unplanned admissions, 2 each with ketamine and N2O. With ketamine, the 2 highest rates of complications were airway repositioning (3.99%) and nausea and/or vomiting (2.98%). With N2O, the 2 highest complication rates were nausea and/or vomiting (8.50%) and airway repositioning (1.10%). Respiratory and cardiovascular events were more frequently encountered with ketamine, whereas nausea/vomiting, sedation level not achieved, and inadequate sedation resulting in procedure not completed occurred more frequently with N2O. CONCLUSIONS: PH at St Louis Children's Hospital successfully provided sedation by using ketamine and N2O with low rates of complications for a variety of procedures.

A proposed mechanism to assess knowledge of pediatric hospitalists to identify and manage rare events during procedural sedation.

OBJECTIVE: The goal of this study was to assess the knowledge of pediatric hospitalists (PHs) in identifying and managing rare events during procedural sedation (PS) with ketamine and nitrous oxide (N2O). METHODS: A Web-based survey with multiple choice questions and case scenarios was used to determine the knowledge of PHs in identifying infrequent contraindications and managing laryngospasm, a rare life-threatening complication during PS. The survey was sent to all PHs at St Louis Children's Hospital. RESULTS: Forty percent of experienced PHs (>50 sedation procedures performed) and 5% of inexperienced PHs (<50 sedation procedures performed) identified all 4 ketamine contraindications. Twenty-one percent of experienced PHs and 4% of inexperienced PHs identified all 6 N2O contraindications. Ninety-five percent of PHs identified presence of laryngospasm in a case scenario. As the patient in the case scenario progressed from partial to complete laryngospasm, 84% and 82% of PHs chose either the preferred or acceptable strategy to manage the patient. With further deterioration in the patient's status in the scenario, 66% and 71% of PHs chose either the preferred or acceptable strategy to manage the patient. The preferred strategy at each step is one that attempted the least invasive maneuver to manage the patient. There was no significant difference between experienced and inexperienced PHs in the management of laryngospasm. CONCLUSIONS: Knowledge gaps exist among PHs regarding contraindications for ketamine and N2O that are infrequently encountered in patients and for the management of laryngospasm, a rare adverse event with ketamine. Ongoing teaching tools are necessary to assess and maintain the knowledge of sedation providers regarding rare events during PS that can improve their proficiency.

Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions.

OBJECTIVE: To evaluate the nature, frequency, and predictors of adverse events during the use of propofol by pediatric hospitalists. STUDY DESIGN: We reviewed 1649 charts of patients sedated with propofol by pediatric hospitalists at St Louis Children's Hospital between January 2005 and September 2009. RESULTS: Hospitalists were able to complete 1633 of the 1649 sedations reviewed (99%). Major complications included 2 patients with aspiration and 1 patient intubated to complete the study. We observed a 74% reduction in the number of patients with respiratory events and airway interventions from 2005 to 2009. Predictors of respiratory events were history of snoring (OR, 2.40; 95% CI, 1.52-3.80), American Society of Anesthesiologists (ASA) physical status classification of ASA 3 (OR, 2.30; 95% CI, 1.22-4.33), age >12 years (OR, 4.01; 95% CI, 2.02-7.98), premedication with midazolam (OR, 1.85; 95% CI, 1.15-2.98), and use of adjuvant glycopyrrolate (OR, 4.70; 95% CI, 2.35-9.40). All except ASA 3 status were also predictors for airway intervention. There was a decline in the prevalence of all of these predictors over the study years (P < .05) except for use of glycopyrrolate. CONCLUSION: Our pediatric hospitalists implemented a successful propofol sedation program that realized a 74% reduction in respiratory events and airway interventions between 2005 and 2009. Decreased prevalence of the predictors of adverse events that we identified likely contributed to this reduction.

Development of a pediatric hospitalist sedation service: training and implementation.

OBJECTIVE: There is growing demand for safe and effective procedural sedation in pediatric facilities nationally. Currently, these needs are being met by a variety of providers and sedation techniques, including anesthesiologists, pediatric intensivists, emergency medicine physicians, and pediatric hospitalists. There is currently no consensus regarding the training required by non-anesthesiologists to provide safe sedation. We will outline the training method developed at St. Louis Children's Hospital. METHODS: In 2003, the Division of Pediatric Anesthesia at St. Louis Children's Hospital approached the Division of Pediatric Hospitalist Medicine as a resource to provide pediatric sedation outside of the operating room. Over the last seven years, Pediatric Hospitalist Sedation services have evolved into a three-tiered system of sedation providers. The first tier provides sedation services in the emergency unit (EU) and the Center for After Hours Referral for Emergency Services (CARES). The second tier provides sedation throughout the hospital including the EU, CARES, inpatient units, Ambulatory Procedure Center (APC), and Pediatric Acute Wound Service (PAWS); it also provides night/weekend sedation call for urgent needs. The third tier provides sedation in all of the second-tier locations, as well as utilizing propofol in the APC. RESULTS: This training program has resulted in a successful pediatric hospitalist sedation service. Based on fiscal year 2009 billing data, the division performed 2,471 sedations. We currently have 43 hospitalists providing Tier-One sedation, 18 Tier-Two providers, and six Tier-Three providers. CONCLUSIONS: A pediatric hospitalist sedation service with proper training and oversight can successfully augment sedation provided by anesthesiologists.

The use of high-dose epinephrine for patients with out-of-hospital cardiopulmonary arrest refractory to prehospital interventions.

OBJECTIVE: To determine if high-dose epinephrine (HDE) used during out-of-hospital cardiopulmonary arrest refractory to prehospital interventions improves return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcomes. METHODS: A multicenter randomized controlled trial was conducted between May 1991 and October 1996 to compare the effectiveness of HDE versus standard-dose epinephrine (SDE) in patients having out-of-hospital cardiopulmonary arrest refractory to prehospital resuscitation efforts. Cardiopulmonary arrest was classified as "medical" or "traumatic." Two hundred thirty patients were enrolled in 7 pediatric emergency departments. Ages ranged from newborn to 22 years. Seventeen patients met exclusion criteria. Patients were assigned to receive HDE (0.1 mg/kg for the initial dose and 0.2 mg/kg for subsequent doses) or SDE (0.01 mg/kg). The main end points evaluated were return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcome. RESULTS: One hundred twenty-seven patients received HDE (32 trauma patients), and 86 patients received SDE (27 trauma patients). Among medical patients, 24 (25%) of 95 experienced return of spontaneous circulation in the HDE group as compared with 9 (15%) of 59 in the SDE group (P = 0.14, chi2 = 2.17, relative risk = 1.66 [0.83-3.31]). Sixteen (17%) of 95 HDE patients and 5 (8%) of 59 SDE patients survived at least 24 hours (P = 0.14, chi2 = 2.16, relative risk = 1.99 [0.77-5.14]). Nine survivors to discharge received HDE, and 2 received SDE (P = 0.21, Fisher exact test, relative risk = 2.75 [0.61-12.28]). There were no long-term survivors among the trauma patients. Eight of 11 long-term survivors had severe neurological outcomes defined by the Glasgow Outcome Scale (2/2 SDE, 6/9 HDE; P = 0.51, Fisher exact test). CONCLUSION: HDE does not improve or diminish return of spontaneous circulation, 24-hour survival, long-term survival, or neurological outcome compared with SDE in out-of-hospital cardiopulmonary arrest.

Pediatric hospitalists fill varied roles in the care of newborns.

The use of hospitalists in the care of newborns appears to be increasing and may be advantageous for several reasons, including decreased cost, decreased length of stay, increased patient survival, increased availability, and greater experience among hospitalists. Research specific to the use of hospitalists in newborn medicine needs to be done to support this hypothesis. Non-clinical activities such as teaching, developing clinical guidelines, and taking an active role in hospital and academic leadership also may improve education and patient care. It is essential that hospitalists who provide care in nurseries work to smooth the transition to a PCP and not act as a barrier. Relatively speaking, the care provided by hospitalists is most often short-term, and the relationship between infants and their parents with the PCP should begin as soon as possible.