Pediatric Sedation Research Consortium Database Research Articles

Anticholinergics and serious adverse events in pediatric procedural sedation: A report of the pediatric sedation research consortiums.

Pediatric sedation is a clinical activity with potential for serious but rare airway adverse events, particularly laryngospasm. Anticholinergic drugs, atropine and glycopyrrolate, are frequently used with the intention to improve sedation safety by virtue of their antisialagogue effects. The objective of this study is to describe the current practice of anticholinergic use in pediatric sedation and to compare the frequency of serious sedation-related adverse events in patients who received anticholinergics to those who did not. We examined prospectively collected data from the Pediatric Sedation Research Consortium database. Patient characteristics, procedure type, sedation provider, sedatives, location of sedation, anticholinergic administered, adverse events, and airway interventions were reported. Propensity score matching and multivariable logistic regression were used to test whether any association exists between anticholinergic use and serious sedation-related adverse events. Anticholinergics were administered in 7.1% (n=18 707) of all cases (n=263 883) reported between November 2011 and October 2017. When anticholinergics were used, atropine was used in 22% (n=4111) and glycopyrrolate in 78.1% (n=14 601) of sedations. Use of anticholinergics was more common in patients with well-described risk factors for airway adverse events: active/history of upper respiratory infection, history of reactive airway disease/asthma, and exposure to smoke. However, infants and ASA 3 patients were not associated with higher rate of anticholinergic use. Anticholinergic use was independently associated with an increase in the odds of serious adverse events, OR 1.8 (95% CI 1.6-2.1), especially airway adverse events. In this large Pediatric Sedation Research Consortium study, we found the use of anticholinergic adjuvants independently associated with greater odds of serious adverse events, especially airway adverse events, after adjusting for well-known sedation risk factors using propensity score matching and multivariate analysis.

The Incidence and Nature of Allergic and Anaphylactic Reactions During Pediatric Procedural Sedation: A Report From the Pediatric Sedation Research Consortium.

Anaphylaxis is rare but life-threatening. Its incidence during pediatric procedural sedation outside of the operating room is unknown. We used data from the Pediatric Sedation Research Consortium (PSRC) to determine the incidence and nature of allergic and anaphylactic reactions in this practice. A retrospective observational study of prospectively collected information in the PSRC's multicenter database was performed. Cases of allergic reaction were identified. Because anaphylaxis is not a listed complication in the PSRC database, all cases for which allergic reaction was noted were reviewed for the occurrence of other complications or interventions that would suggest at least 2 organ system derangements consistent with anaphylaxis as well as for practitioner commentary stating the occurrence of anaphylaxis. Descriptive analyses of demographic information and summary statistics were performed, and multiple logistic regression analysis was used to evaluate associations between the occurrence of allergic reactions and medications. During the study period, 227 833 cases were entered into the PSRC database. There were 54 cases of allergic reaction (incidence 1:4219); 6 were consistent with anaphylaxis (incidence 1:37 972). A significant association between the development of allergic reaction and 4 sedative and/or analgesic medications was noted: midazolam (odds ratio [OR] 2.2; confidence interval [CI] 1.2-3.9), ketamine (OR 3.8; CI 2.1-7.1), methohexital (OR 48.8; CI 14.9-159.9), and morphine (OR 4.4; CI 1.04-18.2). There were no mortalities. Allergic reactions and anaphylaxis during pediatric procedural sedation are rare. In this study, the development of allergic reactions was significantly associated with the use of midazolam, ketamine, methohexital, and morphine.

Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium.

Outcomes associated with a sedative regimen comprised ketamine + propofol for pediatric procedural sedation outside of both the pediatric emergency department and operating room are underreported. We used the Pediatric Sedation Research Consortium database to describe a multicenter experience with ketamine + propofol by pediatric sedation providers. Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the operating room and emergency department using data abstracted from the Pediatric Sedation Research Consortium during 2007-2015. Procedural sedation services from academic, community, free-standing children's hospitals, and pediatric wards within general hospitals. Children from birth to less than or equal to 21 years old. None. A total of 7,313 pediatric procedural sedations were performed using IV ketamine + propofol as the primary sedative regimen. Median age was 84 months (range, < 1 mo to ≤ 21 yr; interquartile range, 36-144); 80.6% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedation was performed in dedicated sedation or radiology units (76.1%). Procedures were successfully completed in 99.8% of patients. Anticholinergics (glycopyrrolate and atropine) or benzodiazepines (midazolam and lorazepam) were used in 14.2% and 41.3%, respectively. The overall adverse event and serious adverse event rates were 9.79% (95% CI, 9.12-10.49%) and 3.47% (95% CI, 3.07-3.92%), respectively. No deaths occurred. Risk factors associated with an increase in odds of adverse event included ASA status greater than or equal to III, dental suite, cardiac catheterization laboratory or radiology/sedation suite location, a primary diagnosis of having a gastrointestinal illness, and the coadministration of an anticholinergic. Using Pediatric Sedation Research Consortium data, we describe the diverse use of IV ketamine + propofol for procedural sedation in the largest reported cohort of children to date. Data from this study may be used to design sufficiently powered prospective randomized, double-blind studies comparing outcomes of sedation between commonly administered sedative and analgesic medication regimens.

Upper Respiratory Infections and Airway Adverse Events in Pediatric Procedural Sedation.

Upper respiratory infections (URIs) are associated with airway adverse events (AAEs) during general anesthesia. There have been no large studies examining the relationship between URIs and AAEs during pediatric procedural sedation. We hypothesized that there would be a relationship between URI status and AAEs in pediatric procedural sedation. We examined prospectively collected data from the Pediatric Sedation Research Consortium database. Specific questions regarding URI status were added to the database to facilitate our analysis. Characteristics of patients, procedure types, adjunctive medications, adverse events, and airway interventions (AIs) were reported. We performed bivariate analysis of adverse events and URI status, then used a multivariable logistic regression model to assess the relationship between URI status and adverse events. We examined the secondary outcome of AI similarly. Of the 105 728 sedations entered into the Pediatric Sedation Research Consortium database during the study period, we were able to use 83 491 for analysis. Controlling for multiple patient, drug, and procedure characteristics, recent and current URI were associated with increased frequency of AAEs. In general, the frequency of AAEs and AIs increased from recent URI, to current URI-clear secretions to current URI-thick secretions. We did not find a relationship between URI status and non-AAEs. URI status is associated with a statistically significant increase in frequency of AAEs and AI during pediatric procedural sedation for the population sedated by our consortium. Although URI status merits consideration in determining potential risk for sedation, rates of some AAEs and AIs remained low regardless of URI status.

Differences in Pediatric Non-Interventional Radiology Procedural Sedation Practices and Adverse Events by Registered Nurses and Physicians

PurposeThe purpose of this study was to determine differences in sedation-related adverse events according to the type of provider monitoring and delivering sedation. Design and MethodsA retrospective, cross-sectional, correlational design using secondary data from the Pediatric Sedation Research Consortium database was used for this study. ResultsA sample of 36,352 cases (0–14 years of age) sedated and monitored for diagnostic radiology procedures by three types of providers (registered nurses [RNs] alone, physicians (MDs) alone, or registered nurse + physician [RN+MD sedation teams]) were compared. Patients sedated by RNs alone or MDs alone had lower odds of unanticipated adverse events (odds ratios 0.46 and 0.53, respectively; p<0.0001) compared with RN+MD sedation provider teams. ConclusionsTeam skills may be an important competency for RN+MD sedation teams in the non-interventional radiology setting. Practice ImplicationsThis study can inform clinicians, administrators, and quality-improvement managers of the differences in adverse event outcomes of pediatric radiology procedures when RN+MD teams provide sedation compared with RNs or MDs alone.

Prevalence and Predictors of Adverse Events during Procedural Sedation Anesthesia-Outside the Operating Room for Esophagogastroduodenoscopy and Colonoscopy in Children

Procedural sedation/anesthesia outside the operating room for a variety of procedures is well described with an overall low adverse event rate in certain settings. Adverse event associated with procedural sedation/anesthesia outside the operating room for gastrointestinal procedures have been described, albeit in small, single-center studies with wide variance in outcomes. Predictors of such outcomes are unclear. We aimed to estimate the prevalence of adverse event in children undergoing procedural sedation/anesthesia outside the operating room for esophagogastroduodenoscopy, colonoscopy, or both to identify predictors of adverse event. Retrospective analysis of Pediatric Sedation Research Consortium database, a large data repository of pediatric patients aged 21 years old or younger undergoing procedural sedation/anesthesia outside the operating room during September 2007 to November 2011. Twenty-two of the 40 centers provided data pertaining to the procedure of interest. None. Primary outcome variable is any adverse event. Independent variables include: age (five groups), sex, American Societyof Anaesthesiologists status, procedure (esophagogastroduodenoscopy, colonoscopy, or both), provider responsible, medication used, location, and presence of coexisting medical conditions. Descriptive statistics used to summarize the data. Using multivariablelogistic regression model, odds ratio, 95% CI) were computed. A total of 12,030 procedures were performed (esophagogastroduodenoscopy, 7,970; colonoscopy, 1,378; and both, 2,682). A total of 96.9% of patients received propofol. Eighty-three percent were performed in a sedation unit. Prevalence of adverse event was 4.8%. The most common adverse event were persistent desaturations (1.5%), airway obstruction (1%), cough (0.9%), and laryngospasm (0.6%). No deaths or CPR occurred. Infants and children aged 5 years old or younger had a higher adverse event rate than older children (15.8%, 7.8% vs 4%). Regression analysis revealed age 5 years old or younger, American Society of Anaesthesiologists greater than or equal to 2, esophagogastroduodenoscopy ± colonoscopy, and coexisting medical conditions of obesity and lower airway disease were independent predictors of higher adverse event. Overall prevalence of any adverse event was 4.8%. Independent predictors of adverse events in procedural sedation/anesthesia outside the operating room in pediatric esophagogastroduodenoscopy/colonoscopy onoscopy were identified. Recognition of such risk factors may enable optimization of procedural sedation.

The impact of obesity on pediatric procedural sedation-related outcomes: results from the Pediatric Sedation Research Consortium.

To evaluate the impact of obesity on adverse events and required interventions during pediatric procedural sedation. The Pediatric Sedation Research Consortium database of prospectively collected procedural sedation encounters was queried to identify patients for whom body mass index (BMI) could be calculated. Obesity was defined as BMI ≥95th percentile for age and gender. Sedation-related outcomes, adverse events, and therapeutic interventions were compared between obese and nonobese patients. For analysis, 28,792 records were eligible. A total of 5,153 patients (17.9%) were obese; they were predominantly male and older and had a higher median American Society of Anesthesiologists Physical Status classification (P < 0.001). Total adverse events were more common in obese patients (odds ratio [OR] 1.49, 95% confidence interval [1.31, 1.70]). Respiratory events (airway obstruction OR 1.94 [1.54, 2.44], oxygen desaturation OR 1.99 [1.50, 2.63], secretions OR 1.48 [1.01, 2.15], laryngospasm OR 2.30 [1.30, 4.05]), inability to complete the associated procedure (OR 1.96 [1.16, 3.30]), and prolonged recovery (OR 2.66 [1.26, 5.59]) were increased in obese patients. Obese patients more frequently required airway intervention including repositioning, suctioning, jaw thrust, airway adjuncts, and bag-valve-mask ventilation. Multivariate regression analysis demonstrated obesity to be independently associated with minor and moderate but not major adverse events. Obesity is an independent risk factor for adverse respiratory events during procedural sedation and is associated with an increased frequency of airway interventions, suggesting that additional vigilance and expertise are required when sedating these patients.

Pediatric critical care physician-administered procedural sedation using propofol: a report from the Pediatric Sedation Research Consortium Database.

Increasing demand for pediatric procedural sedation has resulted in a marked increase in provision of pediatric procedural sedation by pediatric critical care physicians both inside and outside of the ICU. Reported experience of pediatric critical care physicians-administered pediatric procedural sedation is limited. We used the Pediatric Sedation Research Consortium database to evaluate a multicenter experience with propofol by pediatric critical care physicians in all settings. Review of national Pediatric Sedation Research Consortium database to identify pediatric procedural sedation provided by pediatric critical care physicians from 2007 to 2012. Demographic and clinical data were collected to describe pediatric procedural sedation selection, location, and delivery. Multivariable logistic regression analysis was performed to identify risk factors associated with pediatric procedural sedation-related adverse events and complications. A total of 91,189 pediatric procedural sedation performed by pediatric critical care physicians using propofol were included in the database. Median age was 60.0 months (range, 0-264 months; interquartile range, 34.0-132.0); 81.9% of patients were American Society of Anesthesiologists class I or II. Most sedations were performed in dedicated sedation or radiology units (80.9%). Procedures were successfully completed in 99.9% of patients. A propofol bolus alone was used in 52.8%, and 41.7% received bolus plus continuous infusion. Commonly used adjunctive medications were lidocaine (35.3%), opioids (23.3%), and benzodiazepines (16.4%). Overall adverse event incidence was 5.0% (95% CI, 4.9-5.2%), which included airway obstruction (1.6%), desaturation (1.5%), coughing (1.0%), and emergent airway intervention (0.7%). No deaths occurred; a single cardiac arrest was reported in a 13-month-old child receiving propofol and ketamine, with no untoward neurologic sequelae. Risk factors associated with adverse event included: location of sedation, number of adjunctive medications, upper and lower respiratory diagnosis, prematurity diagnosis, weight, American Society of Anesthesiologists status, and painful procedure. Pediatric procedural sedation using propofol can be provided by pediatric critical care physicians effectively and with a low incidence of adverse events.

Meet the Editorial Board Member

Children often require sedation for procedures because of their developmental level and difficulty complying with positioning. There are few studies that describe nurse sedation practices or adverse events. Studies of pediatric sedation care have small sample sizes that are inadequate to detect adverse events. This study reports practices and outcomes of sedation delivered to children from infancy up to 14 years of age, who were monitored only by registered nurses during diagnostic radiology procedures drawn from a sample of 12,584 cases from the Pediatric Sedation Research Consortium database. There were 727 adverse events (5.78%). However, no deaths, cardiac arrests, intubations, or aspirations were reported in this sample. The most common adverse event was inadequate sedation/agitation/delirium 196 (155.8/10,000) and desaturation below baseline for more than 30 s 173 (138/10,000). Further research comparing sedation practices and outcomes by type of providers, including nurses, is necessary to improve practice.

Pediatric Sedation: Using Secondary Data to Describe Registered Nurse Practice in Radiology

Children often require sedation for procedures because of their developmental level and difficulty complying with positioning. There are few studies that describe nurse sedation practices or adverse events. Studies of pediatric sedation care have small sample sizes that are inadequate to detect adverse events. This study reports practices and outcomes of sedation delivered to children from infancy up to 14 years of age, who were monitored only by registered nurses during diagnostic radiology procedures drawn from a sample of 12,584 cases from the Pediatric Sedation Research Consortium database. There were 727 adverse events (5.78%). However, no deaths, cardiac arrests, intubations, or aspirations were reported in this sample. The most common adverse event was inadequate sedation/agitation/delirium 196 (155.8/10,000) and desaturation below baseline for more than 30 s 173 (138/10,000). Further research comparing sedation practices and outcomes by type of providers, including nurses, is necessary to improve practice.

Provision of deep procedural sedation by a pediatric sedation team at a freestanding imaging center

Freestanding imaging centers are popular options for health care systems to offer services accessible to local communities. The provision of deep sedation at these centers could allow for flexibility in scheduling imaging for pediatric patients. Our Children's Sedation Services group, comprised of pediatric critical care medicine and pediatric emergency medicine physicians, has supplied such a service for 5 years. However, limited description of such off-site services exists. The site has resuscitation equipment and medications, yet limited staffing and no proximity to hospital support. To describe the experience of a cohort of pediatric patients undergoing sedation at a freestanding imaging center. A retrospective chart review of all sedations from January 2012 to December 2012. Study variables include general demographics, length of sedation, type of imaging, medications used, completion of imaging, adverse events based on those defined by the Pediatric Sedation Research Consortium database and need for transfer to a hospital for additional care. Six hundred fifty-four consecutive sedations were analyzed. Most patients were low acuity American Society of Anesthesiologists physical class ≤ 2 (91.8%). Mean sedation time was 55 min (SD ± 24). The overwhelming majority of patients (95.7%) were sedated for MRI, 3.8% for CT and <1% (three patients) for both modalities. Propofol was used in 98% of cases. Overall, 267 events requiring intervention occurred in 164 patient encounters (25.1%). However, after adjustment for changes from expected physiological response to the sedative, the rate of events was 10.2%. Seventy-five (11.5%) patients had desaturation requiring supplemental oxygen, nasopharyngeal tube or oral airway placement, continuous positive airway pressure or brief bag valve mask ventilation. Eleven (1.7%) had apnea requiring continuous positive airway pressure or bag valve mask ventilation briefly. One patient had bradycardia that resolved with nasopharyngeal tube placement and continuous positive airway pressure. Fifteen (2.3%) patients had hypotension requiring adjustment of the sedation drip but no fluid bolus. Overall, there were six failed sedations (0.9%), defined by the inability to complete the imaging study. There were no serious adverse events. There were no episodes of cardiac arrest or need for intubation. No patient required transfer to a hospital. Sedation provided at this freestanding imaging center resulted in no serious adverse events and few failed sedations. While this represents a limited cohort with sedations performed by predominately pediatric critical care medicine and pediatric emergency medicine physicians, these findings have implications for the design and potential scope of practice of outpatient pediatric sedation services to support community-based pediatric imaging.

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

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. 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. 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. 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.

Etomidate Versus Pentobarbital for Computed Tomography Sedations

To compare efficacy, sedation duration, and adverse events after administration of etomidate or pentobarbital for diagnostic computed tomography (CT) scans. A cohort of children sedated for CT scans between July 2004 and October 2005 was identified from a prospectively generated Pediatric Sedation Research Consortium database. The 24 Pediatric Sedation Research Consortium institutions prospectively record consecutive sedation data and adverse events on a Web-based tool. This study included all patients of American Society for Anesthesiologists (ASA) class I or II, between 6 months and 6 years old, sedated with etomidate or with intravenous pentobarbital with or without midazolam. Outcomes included sedation efficacy, duration (time from drug administration until cessation of monitoring), and complication rate. Of 3397 pediatric sedations for CT scans, 2587 met age and ASA criteria. Etomidate was administered by pediatric emergency physicians as the sole sedative for 446 sedation service cases; pentobarbital with or without midazolam was used in 396 sedations by a variety of providers. Sedation was "not ideal" for 11 pentobarbital sedations and 1 etomidate sedation. Median etomidate dose was 0.33 mg/kg (intraquartile rank, 0.30-0.44 mg/kg); median pentobarbital dose was 4 mg/kg (intraquartile rank, 3.2-4.8 mg/kg). Mean etomidate sedation (34 minutes; 95% confidence interval [CI], 32-36 minutes) was shorter than pentobarbital (144 minutes; 95% CI, 139-150 minutes). Etomidate patients were younger (24 vs. 29 months), whereas pentobarbital patients were more often of ASA class II (52% vs. 34%), both P < 0.001. Adverse events were more common with pentobarbital (4.5% vs. 0.9%; relative risk, 3.38%; 95% CI, 1.28%-9.45%). One etomidate and 2 pentobarbital patients experienced apnea. Etomidate as given by emergency physicians was more effective and efficient than pentobarbital, with rare adverse events.

Pediatric Procedural Sedation and Analgesia: Practices and Complications

The current literature does not provide an adequate estimate of the type and frequency of adverse events associated with pediatric procedural sedation and analgesia (PSA). In a prospective observational study, researchers evaluated data from the first 30,000 cases submitted to the Pediatric Sedation Research Consortium database, a prospective registry of patients receiving PSA at 35 institutions in the U.S., Canada, Europe, and Australia. Data collection methods were standardized, and definitions were …