Joseph P. Cravero

The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.

OBJECTIVE: We used a large database of prospectively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. PATIENTS AND METHODS: Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedation/anesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. RESULTS: Thirty-seven locations submitted data on 49,836 propofol sedation/anesthesia encounters during the study period from July 1, 2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O2 desaturation below 90% for more than 30 s, occurring 154 times per 10,000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10,000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10,000 encounters, respectively. Unexpected admissions (increases in levels of care required) occurred at a rate of 7.1 per 10,000 encounters. In an unadjusted analysis, the rate of pulmonary adverse events was not different for anesthesiologists versus other providers. CONCLUSIONS: We report the largest series of pediatric propofol sedation/anesthesia for procedures outside the operating room. The data indicate that propofol sedation/anesthesia is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation/anesthesia services. However, the safety of this practice is dependent on a system’s ability to manage less serious events. We propose that our data suggest variables for training and credentialing providers of propofol sedation/anesthesia and the system characteristics that promote safe use of this drug.

Relief of Pain and Anxiety in Pediatric Patients in Emergency Medical Systems

Control of pain and stress for children is a vital component of emergency medical care. Timely administration of analgesia affects the entire emergency medical experience and can have a lasting effect on a child’s and family’s reaction to current and future medical care. A systematic approach to pain management and anxiolysis, including staff education and protocol development, can provide comfort to children in the emergency setting and improve staff and family satisfaction.

Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane

This study was designed to compare the emergence characteristics of sevoflurane with halothane anaesthesia in paediatric patients having no surgical intervention. We randomized 32 ASA I or II paediatric outpatients scheduled for magnetic resonance imaging scans to receive either halothane or sevoflurane anaesthesia. The primary outcome measure was the percentage of patients with emergence agitation, as defined by two different criteria. Time to discharge from the postanaesthesia care unit (PACU) and the secondary recovery unit (SRU) were compared. Sevoflurane patients had a greater incidence of emergence delirium when a high threshold for agitation was defined (33% vs. 0%, P = 0.010) and a lower threshold for agitation was applied (80% vs. 12%, P < 0.0001). Discharge times from the PACU and the SRU were not different. We conclude that there is an increased incidence of emergence agitation with sevoflurane anaesthesia compared to halothane independent of any painful stimulus.

The learning curve associated with a simulated ultrasound-guided interventional task by inexperienced anesthesia residents.

Background and Objective Ultrasound has become an increasingly popular modality in facilitating the performance of peripheral nerve blocks. There exists no literature that examines the learning curve of the ultrasound novice. In this prospective series, we evaluated the learning curve of inexperienced anesthesia residents in performing a simulated ultrasound-guided interventional procedure. In doing so, we hoped to identify reproducible patterns of human errors, which could potentially aid in the prevention of real-life iatrogenic injuries. Methods Ten subjects were prospectively enrolled. After a brief introduction to the ultrasound system, the subjects were asked to perform 6 sequential trials of a simulated breast cyst aspiration. For the first 3 trials, each subject attempted to place a 22-gauge b-bevel needle into any aspect of an olive buried inside the turkey breast. After completion of these 3 trials, the subjects were asked to place the needle into the exact midpoint of the olive wall closest to the transducer. Trials were videotaped and analyzed for task performance in terms of speed and accuracy. Results All subjects successfully completed the 6 interventional trials. The mean time to perform the task was reduced by 38% and 48%, respectively, for the second and third trials. A composite score of accuracy showed an improvement of 36% and 59%, respectively, for the second and third trials. The most common committed error, which occurred in 7 of 10 subjects, was the failure to accurately image the needle while advancing. This resulted in excessive depth of penetration and inadvertent transfixation of the olive in 5 of these subjects. Conclusions Anesthesiology residents, with little or no ultrasound experience, can rapidly learn and improve their speed and accuracy in performing a simulated interventional ultrasound procedure. A concerning novice pattern was identified where the subjects advanced the needle even though it was not appropriately visualized in the ultrasound beam. This resulted in needle placement error, which could cause iatrogenic injury in the clinical setting.

The Effect of Small Dose Fentanyl on the Emergence Characteristics of Pediatric Patients After Sevoflurane Anesthesia Without Surgery

We designed this study to measure the effect of a small dose of IV fentanyl on the emergence characteristics of pediatric patients undergoing sevoflurane anesthesia without any surgical intervention. Thirty-two ASA physical status I or II pediatric outpatients receiving sevoflurane anesthesia for magnetic resonance imaging scans were enrolled and assigned in a random and double-blinded manner to receive either placebo (saline) or 1 &mgr;g/kg IV fentanyl 10 min before discontinuation of their anesthetic. The primary outcome measure was the percentage of patients with emergence agitation. We also evaluated the duration of agitation and time to meet hospital discharge criteria. Patients who received fentanyl had a decreased incidence of agitation (12% versus 56%) when compared with placebo. There was no significant difference in time to meet hospital discharge criteria. We conclude that the addition of a small dose of fentanyl to inhaled sevoflurane anesthesia decreases the incidence of emergence agitation independent of pain control effects.

Review of Pediatric Sedation

Sedating children for diagnostic and therapeutic procedures remains an area of rapid change and considerable controversy. Exploration of this topic is made difficult by the fact that the reports of techniques and outcomes for pediatric sedation appear in a wide range of subspecialty publications and rarely undergo comprehensive examination. In this review article, we will touch on many aspects of the topic of pediatric sedation from the perspective of the anesthesiologist. We begin with a review of the historical role of anesthesiologists in the development of the current standards for pediatric sedation. We also examine the current status of pediatric sedation as reflected in published studies and reports. A specific review of the issues surrounding safety of sedation services is included. Current trends in sedation practice, including the expanding role of potent sedative hypnotic drugs outside the field of anesthesiology, are noted. Finally, we suggest future areas for research and clinical improvement for sedation providers.

Impact of Provider Specialty on Pediatric Procedural Sedation Complication Rates

OBJECTIVE: To determine if pediatric procedural sedation-provider medical specialty affects major complication rates when sedation-providers are part of an organized sedation service. METHODS: The 38 self-selected members of the Pediatric Sedation Research Consortium prospectively collected data under institutional review board approval. Demographic data, primary and coexisting illness, procedure, medications used, outcomes, airway interventions, provider specialty, and adverse events were reported on a self-audited, Web-based data collection tool. Major complications were defined as aspiration, death, cardiac arrest, unplanned hospital admission or level-of-care increase, or emergency anesthesia consultation. Event rates per 10 000 sedations, 95% confidence intervals, and odds ratios were calculated using anesthesiologists as the reference group and were then adjusted for age, emergency status, American Society of Anesthesiologists physical status > 2, nil per os for solids, propofol use, and clustering by site. RESULTS: Between July 1, 2004, and December 31, 2008, 131 751 pediatric procedural sedation cases were recorded; there were 122 major complications and no deaths. Major complication rates and 95% confidence intervals per 10 000 sedations were as follows: anesthesiologists, 7.6 (4.6–12.8); emergency medicine, 7.8 (5.5–11.2); intensivist, 9.6 (7.3–12.6); pediatrician, 12.4 (6.9–20.4); and other, 10.2 (5.1–18.3). There was no statistical difference (P > .05) among providers complication rates before or after adjustment for potential confounding variables. CONCLUSIONS: In our sedation services consortium, pediatric procedural sedation performed outside the operating room is unlikely to yield serious adverse outcomes. Within this framework, no differences were evident in either the adjusted or unadjusted rates of major complications among different pediatric specialists.

Emergence characteristics of sevoflurane compared to halothane in pediatric patients undergoing bilateral pressure equalization tube insertion.

STUDY OBJECTIVE To compare the emergence characteristics of sevoflurane with halothane in pediatric patients having bilateral myringotomy and pressure equalization tube insertion using a highly standardized and common anesthetic technique. DESIGN Prospective, randomized, double-blind study. SETTING University hospital. PATIENTS 43 ASA physical status I and II healthy pediatric outpatients scheduled for initial ear tube placement by one surgeon. INTERVENTIONS Patients were randomized to receive either halothane or sevoflurane as their sole anesthetic drug for ear tube insertion. All patients as well as the research nurse grading emergence agitation were blinded to group assignment. No premedication was administered, and all patients received a standard dose of rectal acetaminophen for postoperative pain control. MEASUREMENT AND MAIN RESULTS The primary outcome was the percentage of patients with emergence agitation, defined as thrashing behavior requiring physical restraint for greater than three minutes. Time to discharge from the postanesthesia care unit (PACU) and from the hospital were also compared. Sevoflurane patients had a greater incidence of emergence delirium: 57% versus 27% [95% CI (1.7%-58.1%) p = 0.047]. Time to discharge from the PACU and the hospital were longer for patients who received sevoflurane: 62 versus 50 min [95% CI (1.4-23.6) p = 0.02] and 102 versus 79 mins [95% CI (9.6-37.1) p = 0.003]. CONCLUSION In our institution there is a trend toward greater emergence agitation in ear tube placement patients given sevoflurane versus halothane anesthesia. Further, (with our discharge criteria) patients are actually discharged from the PACU and the hospital faster when given halothane as a sole anesthetic when compared to sevoflurane.

Emergency Physician–Administered Propofol Sedation: A Report on 25,433 Sedations From the Pediatric Sedation Research Consortium

STUDY OBJECTIVE We describe the adverse events observed in a large sample of children sedated with propofol by emergency physicians and identify patient and procedure characteristics predictive of more serious adverse events. METHODS We identified sedations performed by emergency physicians using propofol as the primary sedative, included in the Pediatric Sedation Research Consortium database from July 2004 to September 2008. We describe the characteristics of the patients, procedures, location, adjunctive medications, and adverse events. We use a multivariable logistic regression model to identify predictors of more serious adverse events. RESULTS Of 25,433 propofol sedations performed by emergency physicians, most (76%) were performed in a radiology department. More serious adverse events occurred in 581 sedations (2.28%; 95% confidence interval 2.1% to 2.5%). There were 2 instances of aspiration, 1 unplanned intubation, and 1 cardiac arrest. Significant predictors of serious adverse events were weight less than or equal to 5 kg, American Society of Anesthesiologists classification greater than 2, adjunctive medications (benzodiazepines, ketamine, opioids, or anticholinergics), nonpainful procedures, and primary diagnoses of upper respiratory illness or prematurity. CONCLUSION We observed a low adverse event prevalence in this largest series of propofol sedations by emergency physicians. Factors indicating greater risk of more serious adverse events are detailed.

Same patients, same critical events--different systems of care, different outcomes: description of a human factors approach aimed at improving the efficacy and safety of sedation/analgesia care.

Abstract The practice of sedating pediatric patients undergoing diagnostic and therapeutic procedures represents an ideal model for evaluating systems of health care delivery. We present detailed evidence of how different systems acting on the same patient under similar conditions result in very different outcomes. In contrast to epidemiological methods, our research follows a Human Factors approach of observing a small number of representative cases in great detail to characterize the critical components and processes of ideal sedation care. In this descriptive article we present a framework by which this work domain can be codified and evaluated. We conclude with a demonstration of how a patient simulator can be used to quantify responses to sedation emergencies. These data constitute the basis for innovating novel sedation care systems and strategies that will optimize safety and efficacy.