Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop.

OBJECTIVES: Sedation and analgesia for infants and children requiring mechanical ventilation in the PICU is uniquely challenging due to the wide spectrum of ages, developmental stages, and pathophysiological processes encountered. Studies evaluating the safety and efficacy of sedative and analgesic management in pediatric patients have used heterogeneous methodologies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) IV hosted a series of multidisciplinary meetings to establish consensus statements for future clinical study design and implementation as a guide for investigators studying PICU sedation and analgesia. DESIGN: Twenty-five key elements framed as consensus statements were developed in five domains: study design, enrollment, protocol, outcomes and measurement instruments, and future directions. SETTING: A virtual meeting was held on March 2-3, 2022, followed by an in-person meeting in Washington, DC, on June 15-16, 2022. Subsequent iterative online meetings were held to achieve consensus. SUBJECTS: Fifty-one multidisciplinary, international participants from academia, industry, the U.S. Food and Drug Administration, and family members of PICU patients attended the virtual and in-person meetings. Participants were invited based on their background and experience. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Common themes throughout the SCEPTER IV consensus statements included using coordinated multidisciplinary and interprofessional teams to ensure culturally appropriate study design and diverse patient enrollment, obtaining input from PICU survivors and their families, engaging community members, and using developmentally appropriate and validated instruments for assessments of sedation, pain, iatrogenic withdrawal, and ICU delirium. CONCLUSIONS: These SCEPTER IV consensus statements are comprehensive and may assist investigators in the design, enrollment, implementation, and dissemination of studies involving sedation and analgesia of PICU patients requiring mechanical ventilation. Implementation may strengthen the rigor and reproducibility of research studies on PICU sedation and analgesia and facilitate the synthesis of evidence across studies to improve the safety and quality of care for PICU patients.

Tracheal Intubation by Advanced Practice Registered Nurses in Pediatric Critical Care: Retrospective Study From the National Emergency Airway for Children Registry (2015-2019).

OBJECTIVES: To describe tracheal intubation (TI) practice by Advanced Practice Registered Nurses (APRNs) in North American PICUs, including rates of TI-associated events (TIAEs) from 2015 to 2019. DESIGN/SETTING: Retrospective study using the National Emergency Airway Registry for Children with all TIs performed in PICU and pediatric cardiac ICU between January 2015 and December 2019. The primary outcome was first attempt TI success rate. Secondary outcomes were TIAEs, severe TIAEs, and hypoxemia. SUBJECTS: Critically ill children requiring TI in a PICU or pediatric cardiac ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 11,012 TIs, APRNs performed 1,626 (14.7%). Overall, TI by APRNs, compared with other clinicians, occurred less frequently in patients with known difficult airway (11.1% vs. 14.3%; p < 0.001), but more frequently in infants younger than 1 year old (55.9% vs. 44.4%; p < 0.0001), and in patients with cardiac disease (26.3% vs. 15.9%; p < 0.0001).There was lower odds of success in first attempt TI for APRNs vs. other clinicians (adjusted odds ratio, 0.70; 95% CI, 0.62-0.79). We failed to identify a difference in rates of TIAE, severe TIAE, and oxygen desaturation events for TIs by APRNs compared with other clinicians. The TI first attempt success rate improved with APRN experience (< 1 yr: 54.2%, 1-5 yr: 59.4%, 6-10 yr: 67.6%, > 10 yr: 63.1%; p = 0.021). CONCLUSIONS: TI performed by APRNs was associated with lower odds of first attempt success when compared with other ICU clinicians although there was no appreciable difference in procedural adverse events. There appears to be a positive relationship between experience and success rates. These data suggest there is an ongoing need for opportunities to build on TI competency with APRNs.

Associations With Severe Desaturation Events Among Children Receiving Noninvasive Respiratory Support at Time of Intubation.

BACKGROUND: Endotracheal intubation is a common procedure associated with adverse events, including severe desaturation. Many patients receive noninvasive respiratory support to reduce the need for intubation. There are minimal data about the association between noninvasive respiratory support and the risk of a severe desaturation event during intubation. We aim to differentiate patients based on the level of noninvasive respiratory support, analyze the severe desaturation event by groups, and identify modifiable risk factors. METHODS: Oral intubations, excluding tube exchanges or re-intubation after unplanned extubation, from October 2018 through July 2020, at the study site were reviewed. A severe desaturation event was defined as [Formula: see text] < 70% or a >15% decrease from baseline in cyanotic heart disease. We analyzed outcomes by 4 groups: room air/nasal cannula (≤0.5 L/kg/min), high-flow nasal cannula (HFNC) (0.5-2 L/kg/min), high HFNC (≥2 L/kg/min), and noninvasive ventilation (NIV). RESULTS: Of 243 subjects who were intubated, 31% were receiving room air/nasal cannula, 25% were receiving HFNC, 18% were receiving high HFNC, and 26% were receiving NIV. Twelve percent of all the subjects had a severe desaturation event. In a univariate analysis, the incidence of a severe desaturation event was similar among all levels of respiratory support (P = .14). A severe desaturation event was more likely in those subjects who were receiving [Formula: see text] ≥ 0.6 at the time of the decision to intubate (19.6%) versus [Formula: see text] < 0.6 (8.1%) (P = .02). The duration of noninvasive respiratory support was longer (5 vs 1 h; P = .02) among those with a severe desaturation event. In a regression analysis, when adjusting for ≥2 intubation attempts pre-intubation, NIV use was independently associated with increased odds of severe desaturation events (odds ratio 3.14, CI 1.08-10.5). CONCLUSIONS: Results of our study suggest that [Formula: see text] > 0.60, the duration of noninvasive respiratory support, and exposure to NIV before an intubation are risk factors of severe desaturation events during intubation.

A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.

BACKGROUND: Enteral ibuprofen was first approved as a prescription drug in 1974 for the US market. An intravenous (IV) ibuprofen formulation is approved for use in children older than 6 months of age, but there are limited studies specifically evaluating the pharmacokinetics and safety in children 1-6 months of age. AIMS: The primary purpose of this study was to evaluate the pharmacokinetics of IV ibuprofen in infants younger than 6 months of age. The secondary objective was to evaluate the safety of single and repeated doses of IV ibuprofen in infants younger than 6 months of age. METHODS: This was an industry-sponsored multi-center study. Institutional Review Board approval and informed parental consent were obtained prior to enrollment. Hospitalized neonates and infants younger than 6 months of age with fever or expected postoperative pain were eligible. Enrolled patients received 10 mg/kg of IV ibuprofen every 6 h, with up to four doses per day. Patients were randomized to two sparse sampling technique pharmacokinetic sample time groups. Group 1 samples were drawn at 0, 30 min, and 2 h, while group 2 samples were drawn at 0 min, 1, and 4 h after administration. RESULTS: A total of 24 children were enrolled in the study, with 15 male patients and 9 female patients. The median age of the cohort was 4.4 months (range 1.1-5.9 months), and the median weight was 5.9 kg (range 2.3-8.8 kg). The arithmetic mean and standard error for peak plasma ibuprofen concentration was 56.28 ± 2.77 µg/mL. Plasma levels declined rapidly with a mean elimination half-life of 1.30 h. Time to peak ibuprofen effect and concentration were similar when compared with older pediatric patients. Clearance and volume of distribution were also similar to those reported in older pediatric patients. No drug-related adverse events were reported. CONCLUSIONS: The pharmacokinetic and short-term safety profiles of IV ibuprofen in pediatric patients 1-6 months of age are comparable to those in children older than 6 months of age. TRIAL REGISTRATION: Clinicaltrials.gov Trial Registration number and date: NCT02583399-Registered July 2017.

2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility.

RATIONALE: A guideline that both evaluates current practice and provides recommendations to address sedation, pain, and delirium management with regard for neuromuscular blockade and withdrawal is not currently available. OBJECTIVE: To develop comprehensive clinical practice guidelines for critically ill infants and children, with specific attention to seven domains of care including pain, sedation/agitation, iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment, and early mobility. DESIGN: The Society of Critical Care Medicine Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility Guideline Taskforce was comprised of 29 national experts who collaborated from 2009 to 2021 via teleconference and/or e-mail at least monthly for planning, literature review, and guideline development, revision, and approval. The full taskforce gathered annually in-person during the Society of Critical Care Medicine Congress for progress reports and further strategizing with the final face-to-face meeting occurring in February 2020. Throughout this process, the Society of Critical Care Medicine standard operating procedures Manual for Guidelines development was adhered to. METHODS: Taskforce content experts separated into subgroups addressing pain/analgesia, sedation, tolerance/iatrogenic withdrawal, neuromuscular blockade, delirium, PICU environment (family presence and sleep hygiene), and early mobility. Subgroups created descriptive and actionable Population, Intervention, Comparison, and Outcome questions. An experienced medical information specialist developed search strategies to identify relevant literature between January 1990 and January 2020. Subgroups reviewed literature, determined quality of evidence, and formulated recommendations classified as "strong" with "we recommend" or "conditional" with "we suggest." Good practice statements were used when indirect evidence supported benefit with no or minimal risk. Evidence gaps were noted. Initial recommendations were reviewed by each subgroup and revised as deemed necessary prior to being disseminated for voting by the full taskforce. Individuals who had an overt or potential conflict of interest abstained from relevant votes. Expert opinion alone was not used in substitution for a lack of evidence. RESULTS: The Pediatric Pain, Agitation, Neuromuscular Blockade, and Delirium in critically ill pediatric patients with consideration of the PICU Environment and Early Mobility taskforce issued 44 recommendations (14 strong and 30 conditional) and five good practice statements. CONCLUSIONS: The current guidelines represent a comprehensive list of practical clinical recommendations for the assessment, prevention, and management of key aspects for the comprehensive critical care of infants and children. Main areas of focus included 1) need for the routine monitoring of pain, agitation, withdrawal, and delirium using validated tools, 2) enhanced use of protocolized sedation and analgesia, and 3) recognition of the importance of nonpharmacologic interventions for enhancing patient comfort and comprehensive care provision.

Analysis of Viscoelastic Testing in Pediatric Patients Using the Pediatric Extracorporeal Membrane Oxygenation Outcomes Registry.

Use of viscoelastic tests (VETs), including thromboelastography (TEG) and rotational thromboelastometry (ROTEM), is increasing in the management of anticoagulation in extracorporeal membrane oxygenation (ECMO) patients. A retrospective review of data on 265 pediatric (<20 years old) ECMO patients who underwent VET and were submitted to the Pediatric ECMO Outcomes Registry (PEDECOR) was conducted to describe common coagulopathies in patients who underwent VET; associations between the VET parameters and traditional tests of coagulation; and comparisons in blood product usage in patients who underwent VET with those who did not. We calculated patient-level summary statistics and assessed differences between the groups using χ2 tests (categorical variables) and Kruskal-Wallis and Wilcoxon rank-sum tests (continuous variables). Viscoelastic test was utilized in 77% of patients in the analysis. Platelet dysfunction was the most common abnormality identified by TEG (30.8%) and ROTEM (9.7%). Bleeding patients who had VET performed received more cryoprecipitate transfusions than those who did not have VET (VET median = 9.7 ml/kg; interquartile range (IQR) = 4.3-22.0 ml/kg vs. no VET median = 5.1 ml/kg; IQR = 0-10.4 ml/kg; p = 0.0013). Given the growing use of VET in pediatric ECMO patients, further studies evaluating VET in managing complications as well as aiding in titration of anticoagulation therapy are needed.

Safety of prolonged magnesium sulfate infusions during treatment for severe pediatric status asthmaticus.

OBJECTIVE: Magnesium sulfate (Mg) is one of several "second-tier" therapies for treating severe status asthmaticus. Pediatric reports primarily describe bolus use with limited data regarding prolonged infusions. We sought to describe the safety of prolonged Mg infusions during therapy of status asthmaticus in critically ill children. DESIGN: Single center, retrospective study. SETTING: Thirty-four-bed tertiary level medical/surgical/cardiac surgical pediatric intensive care unit. PATIENTS: Pediatric patients 2 to 18 years of age admitted with status asthmaticus receiving Mg infusion for more than 24 hours. INTERVENTIONS: None. MEASUREMENTS AND MAIN FINDINGS: A total of 154 children received Mg infusions for a median of 53.4 hours (interquartile range = 36.6-74.8). The most common adverse event (AE) was hypotension (48.1%), almost exclusively diastolic (94%), and was mostly limited to 1 blood pressure measurement (78%). 2.9% of events required intervention (fluids, decrease Mg infusion). Other AEs included nausea/emesis (22.7%), transient weakness (14.9%), and flushing (6.5%). Five patients experienced serious AEs including hypotonia (n = 1), escalation to continuous or bilevel positive airway pressure (n = 3), and sedation (n = 1), all attributed to progression of underlying medical disease. No patient required endotracheal intubation. Supratherapeutic levels (>6 mg/dL) were uncommon (2%) and were not more likely to be associated with AEs. Most (81%) patients were therapeutic by the 2nd Mg level check. CONCLUSION: Prolonged Mg infusions were well tolerated in pediatric status asthmaticus patients. While diastolic hypotension was not uncommon, rarely were interventions deemed necessary. No serious AEs were attributed to Mg. Toxicity was uncommon suggesting that Mg levels could potentially be checked less frequently than historically reported.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Procedural sedation in children with autism spectrum disorders: A survey of current practice patterns of the society for pediatric sedation members.

BACKGROUND: Children with autism spectrum disorder are challenging to sedate because of communication, sensory, and behavioral challenges. AIMS: The aim of this survey was to determine how procedural sedation is provided to children with autism spectrum disorders and whether sedation programs have specialized protocols for procedural sedation of these children. METHODS: We surveyed physician Medical Directors of sedation programs who are members of the Society for Pediatric Sedation, asking about practice characteristics and resource utilization during procedural sedation of children with autism spectrum disorders. RESULTS: Of 58 directors, 47 (81%) responded. Of the programs surveyed, 53% were either a large university medical center and 40% were a freestanding children's hospital. Only (12/47, 25.5%) of the programs used an individualized autism coping plan. To accomplish procedural sedation in this study cohort, 36% of the programs used additional nurses, whereas a child life specialist was used in 55% of the programs surveyed. Only 28% of the centers allotted additional time to accommodate children with autism spectrum disorders. Distraction methods were used in 80% whereas restrains were used in 45% programs for were used most commonly for i.v. catheter placement. Propofol was the preferred agent for 70% of programs for imaging, while propofol + fentanyl was used by 66% of programs for painful procedures. Although 57% of directors reported that their program staff was extremely comfortable providing procedural sedation for children with autism spectrum disorder, 79% of the directors wanted more education about behavioral management strategies for procedural sedation of these children. CONCLUSION: Among the Society for Pediatric Sedation programs, significant institutional variation exists on the delivery of procedural sedation to children with autism spectrum disorders. A better understanding of resources required, standardization of behavioral management strategies and pharmacologic approaches, and protocol development may help optimize care to this vulnerable population.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

When the Mannequin Dies, Creation and Exploration of a Theoretical Framework Using a Mixed Methods Approach.

INTRODUCTION: Controversy exists in the simulation community as to the emotional and educational ramifications of mannequin death due to learner action or inaction. No theoretical framework to guide future investigations of learner actions currently exists. The purpose of our study was to generate a model of the learner experience of mannequin death using a mixed methods approach. METHODS: The study consisted of an initial focus group phase composed of 11 learners who had previously experienced mannequin death due to action or inaction on the part of learners as defined by Leighton (Clin Simul Nurs. 2009;5(2):e59-e62). Transcripts were analyzed using grounded theory to generate a list of relevant themes that were further organized into a theoretical framework. With the use of this framework, a survey was generated and distributed to additional learners who had experienced mannequin death due to action or inaction. Results were analyzed using a mixed methods approach. RESULTS: Forty-one clinicians completed the survey. A correlation was found between the emotional experience of mannequin death and degree of presession anxiety (P < 0.001). Debriefing was found to significantly reduce negative emotion and enhance satisfaction. Sixty-nine percent of respondents indicated that mannequin death enhanced learning. These results were used to modify our framework. CONCLUSIONS: Using the previous approach, we created a model of the effect of mannequin death on the educational and psychological state of learners. We offer the final model as a guide to future research regarding the learner experience of mannequin death.

Options and Considerations for Procedural Sedation in Pediatric Imaging.

As pediatric imaging capabilities have increased in scope, so have the complexities of providing procedural sedation in this environment. While efforts by many organizations have dramatically increased the safety of pediatric procedural sedation in general, radiology sedation creates several special challenges for the sedation provider. These challenges require implementation of additional safeguards to promote safety during sedation while maintaining effective and efficient care. Multiple agent options are available, and decisions regarding which agent(s) to use should be determined by both patient needs (i.e., developmental capacities, underlying health status, and previous experiences) and procedural needs (i.e., duration, need for immobility, and invasiveness). Increasingly, combinations of agents to either achieve the conditions required or mitigate/counterbalance adverse effects of single agents are being utilized with success. To continue to provide effective imaging sedation, it is incumbent on sedation providers to maintain familiarity with continuing evolutions within radiology environments, as well as comfort and competence with multiple sedation agents/regimens. This review discusses the challenges associated with radiology sedation and outlines various available agent options and combinations, with the intent of facilitating appropriate matching of agent(s) with patient and procedural needs.

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

OBJECTIVES: To evaluate the impact of obesity on adverse events and required interventions during pediatric procedural sedation. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Development, implementation, and initial participant feedback of a pediatric sedation provider course.

BACKGROUND: No standardized educational curriculum exists for pediatric sedation practitioners. We sought to describe the curriculum and implementation of a pediatric sedation provider course and assess learner satisfaction with the course curriculum. DESCRIPTION: The course content was determined by formulating a needs assessment using published sedation guidelines, reports of sedation related adverse events, and a survey of sedation practitioners. Students provided feedback regarding satisfaction with the course immediately following the course and 6 months later. EVALUATION: The course consisted of 5 didactic lectures, 1 small-group session, 6 simulation scenarios, a course syllabus, and a written examination. The course was conducted over 1 day at 3 different locations. Sixty-nine students completed the course and were uniformly satisfied with the course curriculum. CONCLUSIONS: A standardized pediatric sedation provider course was developed for sedation practitioners and consisted of a series of lectures and simulation scenarios. Overall satisfaction with the course was positive.

Pretreatment with midazolam blunts the rise in intracranial pressure associated with ketamine sedation for lumbar puncture in children.

OBJECTIVE: Ketamine has a long history of use during pediatric procedural sedation. Concerns about raising intracranial pressure may limit use in certain situations. Whereas some data suggest that benzodiazepine coadministration may blunt this response, pediatric data during procedural sedation do not exist. We evaluated the effects of midazolam pretreatment on intracranial pressure during ketamine sedation in children. DESIGN: Prospective, randomized clinical study. SETTING: Outpatient Medical Observation unit at Kosair Children's Hospital. PATIENTS: A total of 25 oncology patients in whom sedated lumbar puncture was scheduled. INTERVENTIONS: Patients alternated between sedation in Group A (midazolam/ketamine prior to lumbar puncture) or Group B (ketamine only prior to lumbar puncture). Opening pressure, medication doses, sedation depth, and complications were recorded. A control group of non-ketamine-sedated patients (Group C) was added to differentiate drug vs. disease-specific opening pressure changes. Between-group differences were compared by linear mixed effects model or contingency table with p < 0.05 considered significant. MEASUREMENTS AND MAIN RESULTS: Twenty-five patients aged 82 ± 49 months were sedated 84 times. Thirty-five sedations were in Group A, 39 in Group B, and 10 in Group C. Mean (95% confidence interval) adjusted opening pressure in Group A (22.0 [12.3, 22.2] cm H2O) was lower than Group B (26.5 [24.0, 29.2] cm H2O, p = 0.013). Opening pressure in Group C (17.3 [12.3, 22.2] cm H2O) was lower than in Group B (p = 0.002) but not in Group A (p = 0.096). Ketamine doses were similar between Groups A and B (1.4 ± 0.6 mg/kg vs. 1.4 ± 0.4 mg/kg, p = NS). Mean midazolam pretreatment dose was 0.09 ± 0.02 mg/kg and did not correlate with measured opening pressure. Four patients, all in Group B, experienced significant emergence reactions. CONCLUSION: While pretreatment with midazolam is associated with a reduction in intracranial pressure compared with sedation with ketamine alone, ketamine-containing regimens are associated with higher opening pressures than non-ketamine-containing regimens.

Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease.

OBJECTIVE: To determine the efficacy and adverse effect profile of clevidipine when used for perioperative blood pressure (BP) control during surgery for congenital heart disease (CHD). METHODS: We retrospectively reviewed our experience with the perioperative use of clevidipine in pediatric-aged patients undergoing surgery for CHD. RESULTS: The study cohort included 14 patients ranging from 11 months to 15 years (7.4 ± 4.6 years) and weighing from 5 to 41 kg (21.8 ± 11.1 kg). Clevidipine was administered as a continuous infusion for control of either postoperative BP or intraoperative mean arterial pressure (MAP) during cooling and cardiopulmonary bypass (CPB). It was administered as a bolus for BP control during emergence from anesthesia following cardiac surgery. The continuous infusion was started at 1 mcg/kg/min and increased in increments of 0.5 to 1 mcg/kg/min as needed. For postoperative BP control, dosing requirements varied from 1 to 7 mcg/kg/min (mean = 2.0 ± 1.2 mcg/kg/min). The target BP was achieved within 5 minutes in all patients. Two patients were treated with intravenous or oral propranolol for an increase in heart rate (HR) while receiving clevidipine. Despite doses up to 10 mcg/kg/min, effective control of MAP could not be achieved during CPB and cooling (core body temperature 28°C to 32°C). Bolus doses of clevidipine (10 to 15 mcg/kg) controlled BP during emergence from anesthesia with a decrease of the MAP from 97 ± 6 mm Hg to 71 ± 5 mm Hg (p<0.01). CONCLUSIONS: Clevidipine is effective for perioperative BP control in infants and children with CHD; however, it does not appear effective in controlling MAP during cooling and CPB.