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Etomidate versus midazolam for procedural sedation in pediatric outpatients: a randomized controlled trial.

STUDY OBJECTIVE: Midazolam is widely used for procedural sedation and analgesia. Etomidate has been studied mostly in adults. Our objective is to compare the efficacy of etomidate and midazolam for achieving procedural sedation and analgesia in children. METHODS: A randomized, double-blind, emergency department and orthopedic clinic-based trial was carried out among patients aged 2 to 18 years with displaced extremity fractures. Patients were administered 1 microg/kg of fentanyl and either 0.2 mg/kg of etomidate or 0.1 mg/kg of midazolam. Adequate sedation was defined, for the purpose of this study, as a score of 4 or more on the Ramsay Sedation Scale. The primary outcome was induction and recovery time. The rates of adverse events, success of fracture reduction, and parent and physician satisfaction were also compared. RESULTS: From April to August 2004, 100 of 128 eligible patients were enrolled (age 8.7+/-3.7 years; 50% male patients). A higher proportion of patients attained adequate sedation among those who received etomidate: 46 of 50 (92%) versus 18 of 50 (36%) (delta 56%; 95% confidence interval [CI] 38% to 69%). Time taken for induction (hazard ratio 4.9; 95% CI 2.2 to 10.9) and time taken for recovery (hazard ratio 2.8; 95% CI 1.5 to 5.1) were lower among patients who received etomidate. The rates of adverse events were similar in both groups, except for myoclonus and pain at the injection site, which was more frequent in the etomidate group. CONCLUSION: Induction and recovery times are shorter with etomidate compared with midazolam. At the dosages used for procedural sedation and analgesia among children with displaced extremity fracture, etomidate has higher efficacy in comparison with midazolam.

Adolescent↗

Preprocedural fasting state and adverse events in children receiving nitrous oxide for procedural sedation and analgesia.

STUDY OBJECTIVE: Established fasting guidelines for analgesia and sedation are difficult to follow in the emergency department (ED), and the association between preprocedural fasting and adverse events has been questioned. We characterize the fasting status of patients receiving procedural sedation and analgesia with nitrous oxide (N2O) in a pediatric ED and assess the relationship between fasting status and adverse events. METHODS: A prospective case series was conducted in a children's hospital ED over an 8-month period. Patients receiving N2O for procedural sedation and analgesia were enrolled and followed up by telephone call. Preprocedural fasting state and adverse events, as well as N2O concentration, adjunctive drugs, and deepest level of sedation, were recorded. Adverse events were analyzed in relation to fasting status. RESULTS: Two hundred twenty children who underwent procedural sedation and analgesia with N2O were enrolled. Fasting status was obtained in 218 patients (99.1%). Of these, 155 (71.1%; 95% confidence interval [CI], 64.5%-77.0%) did not meet fasting guidelines for solids There were no serious adverse events and no episodes of aspiration (1-sided 97.5% CI, 0%-1.7%). While in the ED, 46 minor adverse events occurred in 37 patients (16.8%; 95% CI, 12.1%-22.4%). Emesis occurred in 15 patients (7%), including 4 (6.3%; 95% CI, 1.8%-15.5%) of 63 patients who met and in 11 (7.1%; 95% CI, 3.6%-12.3%) of 155 patients who did not meet fasting guidelines for solids. There was no significant difference in median fasting duration between patients with and without emesis. CONCLUSION: Seventy-one percent of patients undergoing ED procedural sedation and analgesia with N2O did not meet established fasting guidelines. In this series, there was no association between preprocedural fasting and emesis. There were no serious adverse events.

Administration, Inhalation↗

Emergency department procedural sedation and analgesia: A Canadian Community Effectiveness and Safety Study (ACCESS).

OBJECTIVES: To determine the effectiveness and safety of procedural sedation and analgesia (PSA) in a Canadian community emergency department (ED) staffed primarily by family physicians and to assess the role of capnometry monitoring in PSA. METHODS: One hundred and sixty (160) consecutive procedural sedation cases were reviewed from the ED of a rural hospital in Huntsville, Ont. The ED is mainly staffed by family physicians who have received in-house training in PSA. Safety and effectiveness measures were extrapolated from a standardized PSA form by a blinded research assistant. RESULTS: The mean age of the patient population was 33.6 years (standard deviation = 23.6). Fifty-four percent of the patients were male, and 33% of the cases were pediatric. PSA medications included propofol (84%), fentanyl (51%) and midazolam (15%), and the procedural success rate was 95.6%. The adverse event (AE) rate was 18% and included apnea (10%), inadequate sedation (3%), bradycardia (2%), desaturation (1%), hypotension (1%) and bag-valve-mask use (1%). In those aged > or = 65 years there was a greater incidence of apnea. There were no episodes of emesis and there were no intubations. A modified jaw thrust manoeuvre was used in 23% of the cases. I the 64% of cases where capnometry was used, there was no association between its use and any AE measures. CONCLUSION: Procedural sedation was safe and effective in our environment. Capnometry recording did not appear to alter outcomes, although the data are incomplete.

Adolescent↗

Adverse events of premixed nitrous oxide and oxygen for procedural sedation in children.

In France, administration of premixed 50% nitrous oxide and oxygen for procedural sedation is under close supervision by the French Drug Agency before final approval for use. We have examined the frequency of adverse events in children sedated with 50% nitrous oxide and oxygen over a broad range of non-specialised facilities. A mean of 0.33% (SD 0.10) children had major adverse events. Thus, premixed 50% nitrous oxide and oxygen seems to be a safe option for procedural sedation in children.

Adolescent↗

Procedural sedation and analgesia: a review and new concepts.

Procedural sedation and analgesia has become a commonplace procedure in the ED, certainly falling under the domain of the EP. Every EP should approach PSA as a complex procedure requiring high-level skills and knowledge. Initially, understand that PSA represents a spectrum of goals, from anxiolysis and pain relief to deep sedation. Assess the needs of the patient and the concomitant procedure and set goals accordingly. There is a pharmacopia of drugs that provide sedation and analgesia. Become familiar with their pharmacology, advantages and disadvantages, and indications. This will allow for appropriate usage and achievement of sedation goals. Several drugs that are commonly used for general anesthesia are proving themselves to be safe and efficacious for PSA. Both etomidate and propofol have emerged as useful drugs for PSA. Continued research and practice with these agents will add to our understanding and help define their use for PSA. Performing PSA as a procedure itself requires preparedness, diligent monitoring, and risk awareness. Knowing the patient's comorbid state and choosing agents that will not exacerbate their baseline status minimize risk. Following fasting guidelines is appropriate in certain clinical situations, and is prudent when time permits. However, these guidelines are a benchmark for minimizing risk and are not supported by evidence-based medicine. It is important to be cognizant of the guidelines but also to identify the emergency scenario where action must be taken despite the fasting guidelines. Controlling sedation depth also minimizes the risk of aspiration and other complications. The ETCO2 monitor and Bispectral Index may prove to be useful adjuncts for monitoring sedation depth. However, there is nothing yet that measures sedation depth quantitatively that can replace the qualitative assessment of the EP. More and more PSA is falling under the domain of the EP. It is important for the EP to be involved in hospital policy and guidelines associated with this procedure, and to remain aware of new research in this field. EPs can thereby contribute to quality assurance throughout the medical community by setting a standard in the practice of PSA, as they are not the only practitioners using this procedure. With continued practice and research, expertise in this field will grow measurably.

Analgesia↗

Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model.

OBJECTIVE: Guidelines for risk reduction during procedural sedation from the American Academy of Pediatrics (AAP) and the American Society of Anesthesiologists (ASA) rely on expert opinion and consensus. In this article, we tested the hypothesis that application of an AAP/ASA-structured model would reduce the risk of sedation-related adverse events. METHODS: Prospectively coded sedation records were abstracted by a hospital quality improvement specialist with practical and administrative experience in pediatric sedation. Process variables included notation of nulla per os (NPO) status, performance of a guided risk assessment, assignment of ASA physical status score, obtaining informed consent, generation of a sedation plan, and assessment of sedation level using a quantitative scoring system. Content variables included adherence to AAP NPO guidelines, ASA class, target sedation level, actual sedation level, age, procedure, and drugs used. Complication risk was assessed by logistic regression and Mantel-Haenszel odds ratios (OR). RESULTS: Complications were identified in 40 of 960 records (4.2%). The complication rate was 34 of 895 (3.8%) with planned conscious sedation and 6 of 65 (9.2%) with planned deep sedation ([DS]; OR: 2.6). Complications were reduced by performance of structured risk assessment (OR: 0.10), adherence to all process guidelines (OR: 0), and avoiding actual DS (OR: 0.4). The only drug associated with higher risk was chloral hydrate (OR: 2.1). Failure to adhere to NPO guidelines did not increase risk in this assessment; however, the adverse event rate was 0 if all process guidelines were followed. CONCLUSIONS: Presedation assessment reduces complications of DS. Repeated assessment of sedation score reduces the risk of inadvertent DS. The data provide direct evidence that AAP/ASA guidelines can reduce the risk of pediatric procedural sedation.

Anesthesia↗

Newer pharmacologic agents for procedural sedation of children in the emergency department-etomidate and propofol.

Procedural sedation for pediatric patients having painful or anxiety-producing procedures is a necessary but often a daunting task for emergency medicine providers. This article focuses on the two agents that have most recently been described for use in this population-etomidate and propofol. Etomidate is a nonbarbiturate sedative hypnotic agent with no analgesic properties. Its rapid onset of action, short duration of action, and minimal hemodynamic effects make it an attractive agent for use in procedural sedation. Similar to previous adult studies, recent studies have shown that etomidate is both safe and effective in this pediatric population. Propofol is also a sedative hypnotic agent with rapid onset and short duration of action. Typically, it is administered as a bolus injection followed by an infusion. It has long been used for surgical procedures as well as in the intensive care unit setting, but little literature has supported its use in the pediatric emergency department. Recent studies appear to support propofol's use in this setting; however, a significant rate of side effects, including hypoxia, apnea, and decreased blood pressure, may limit its use.

Child↗

Safe and efficacious use of procedural sedation and analgesia by non-anesthesiologists in a pediatric hematology-oncology unit.

BACKGROUND: Children often require relief of pain and anxiety while undergoing diagnostic and therapeutic procedures. Procedural sedation and analgesia (PSA) is the safe and effective control of pain, anxiety and motion so as to allow a necessary procedure to be performed and to provide an appropriate degree of memory loss or decreased awareness. OBJECTIVE: To prospectively describe procedural sedation and analgesia as performed in the pediatric oncology unit and to report the success of sedation and the incidence of complications. METHODS: IV Midazolam and IV Ketamine were used for PSA in pediatric oncology patients undergoing painful procedures. RESULTS: Between June 2004 and December 2004, 55 diagnostic and therapeutic procedures were performed using PSA in 16 children. There were 9 boys and 7 girls with a median age of 11 years. Twelve patients had hematolymphoid malignancies and 4 patients had solid tumors. The indication for PSA were bone marrow aspiration and or biopsy in 7 patients, therapeutic lumbar puncture in 43 patients, bone marrow aspiration and lumbar puncture in 4 patients and skin biopsy in 1 patient. All 55 procedures were successfully completed. Adverse events occurred in 15 (27%) episodes and included transient drop in oxygen saturation, vomiting, dizziness and disinhibition with crying spells. Average time to arousable state and full recovery was 22 minutes and 31 minutes respectively. None of the patients complained of post procedure pain nor recalled the procedure at the follow up visit. CONCLUSION: Procedural sedation and analgesia using midazolam and ketamine is a safe and efficient method of limiting anxiety and procedure related pain and can be successfully administered by non-anaesthesiologists. The complication rate is low and can be easily managed.

Adolescent↗

Procedural sedation in the pediatric patient.

The demand for safe and effective procedural sedation for children is rapidly increasing because of the increased awareness about procedure-related anxiety even in young infants and children. The development of short-acting sedatives, improved monitoring, and new regulatory requirements have led to the evolution of new paradigms of safe, effective, and resource-efficient systems for providing procedural sedation outside the operating rooms by anesthesiologists and nonanesthesiologists.

Anesthesia↗

Propofol for procedural sedation in children in the emergency department.

STUDY OBJECTIVE: We determine the safety and efficacy of propofol sedation for painful procedures in the emergency department (ED). METHODS: A consecutive case series of propofol sedations for painful procedures in the ED of a tertiary care pediatric hospital from July 2000 to July 2002 was performed. A sedation protocol was followed. Propofol was administered in a bolus of 1 mg/kg, followed by additional doses of 0.5 mg/kg. Narcotics were administered 1 minute before propofol administration. Adverse events were documented, as were the sedation duration, recovery time from sedation, and total time in the ED. RESULTS: Three hundred ninety-three discrete sedation events with propofol were analyzed. Procedures consisted of the following: fracture reductions (94%), reduction of joint dislocations (4%), spica cast placement (2%), and ocular examination after an ocular burn (0.3%). The median propofol dose was 2.7 mg/kg. Ninety-two percent of patients had a transient (<or=2 minutes) decrease in systolic blood pressure without clinical signs of poor perfusion. Nineteen (5%) patients had hypoxia, 11 (3%) patients required airway repositioning or jaw-thrust maneuvers, and 3 (0.8%) patients required bag-valve-mask ventilation. No patient required endotracheal intubation. CONCLUSION: Propofol sedation is efficacious and can be used safely in the ED setting under the guidance of a protocol. Transient cardiopulmonary depression occurs, which requires vigilant monitoring by highly skilled practitioners. Propofol is well suited for short, painful procedures in the ED setting.

Adjuvants, Anesthesia↗

Propofol for deep procedural sedation in the ED.

UNLABELLED: We sought to evaluate the use of propofol (2,6-diisopropylphenol) for ED procedural sedation, particularly when administered in a routine fashion for a variety of indications. METHODS: This was a prospective observational study conducted in an urban teaching ED. Propofol was administered by handheld syringe and combined with fentanyl. Measurements included propofol and fentanyl dose, serial vital signs, pulse oximetry, adverse events, and patient and physician satisfaction. RESULTS: One hundred thirty-six subjects (18 to 69 years) were enrolled. Procedures included 82 (60.3%) abscess incision and drainages and 47 (34.6%) orthopedic reductions. Adverse events occurred in 14 cases (10.3%; 95% confidence interval 5.2% to 15.4%), including hypotension in 5, hypoxemia in 7, and apnea in 5. One patient required intubation. Both patient and physician satisfaction were excellent. CONCLUSIONS: ED procedural sedation with propofol was effective and well accepted by patients and physicians. However, it produced a significant incidence of hypotension, hypoxemia, and apnea.

Adolescent↗

Pulmonary aspiration risk during emergency department procedural sedation--an examination of the role of fasting and sedation depth.

The assessment of pre-procedure fasting and control of sedation depth are prominent elements of widely disseminated procedural sedation guidelines and of the Joint Commission on Accreditation of Healthcare Organizations' standards. Both exist primarily to minimize the risk of pulmonary aspiration of gastric contents. This paper critically examines the literature on pre-procedure fasting and controlling sedation depth in association with pulmonary aspiration, and interprets this evidence in the context of modern emergency medicine practice. The article reviews the pathophysiology of aspiration and changing concepts regarding aspiration risk over the last decade. After reviewing studies on aspiration risk during general anesthesia, the paper reviews the risk of aspiration during labor and delivery as a more appropriate comparison group for aspiration risk during emergency department procedural sedation and analgesia (ED PSA). It is noted that aspiration during ED PSA has not been reported in the medical literature and that aspiration during general anesthesia and labor and delivery is uncommon. The literature provides no compelling evidence to support specific fasting periods for either liquids or solids prior to PSA, and existing guidelines for elective patients are of necessity arbitrary and based upon consensus opinion. The article discusses the implications in the areas of training and preparedness, monitoring, and research for the emergency physician practicing PSA.

Anesthesia, General↗

Capnography for procedural sedation and analgesia in the emergency department.

Although it is standard of care for patient safety monitoring in anesthesia, capnography is not routinely used for emergency department procedural sedation and analgesia. We discuss the use of capnography as a diagnostic monitoring modality for procedural sedation and analgesia, focusing on the physiology and interpretation of the CO2 waveform and recognition of normal, abnormal, and drug-induced ventilatory patterns.

Analgesia↗

Comparison of propofol/fentanyl versus ketamine/midazolam for brief orthopedic procedural sedation in a pediatric emergency department.

PURPOSE: To compare the effectiveness of 2 medication regimens, propofol/fentanyl (P/F) and ketamine/midazolam (K/M), for brief orthopedic emergency department procedural sedation. This study was powered to compare recovery times (RT) and procedural distress as measured by the Observational Score of Behavioral Distress-revised (OSBD-r; range: 0-23.5 with 23.5 representing maximal distress). METHODS: We conducted a prospective, partially-blinded controlled comparative trial comparing intravenous P/F with K/M in a convenience sample of 113 patients aged 3 to 18 years old undergoing orthopedic procedural sedation. All medications were administered by the intermittent intravenous bolus method. An independent sedation nurse recorded total sedation time and RT. Effectiveness was measured using 6 parameters: 1) patient distress as assessed by independent blinded observers after videotape review using the OSBD-r; 2) orthopedic satisfaction score (Likert scale 1-5); 3) sedation nurse satisfaction score (Likert 1-5); 4) parental perception of procedural pain using a 0 to 100 mm Visual Analog Scale with the upper limit being "most pain"; 5) patient recall of the procedure; and 6) 1 to 3 week follow-up. RESULTS: RT and total sedation time were significantly less in the P/F group than in the K/M group (33.4 minutes vs 23.2 minutes). The mean OSBD-r scores during manipulation were 0.084 and 0.278 for the K/M and P/F groups, respectively. Although this difference was statistically significant (95% confidence interval for the mean difference -0.34 to -0.048), both regimens were successful in keeping the scores low. There was no statistical difference between the groups in the other measures of effectiveness. There was a statistically significant difference between the groups in the occurrence of desaturation and late side effects. CONCLUSIONS: RT with P/F is shorter than with K/M. P/F is comparable to K/M in reducing procedural distress associated with painful orthopedic procedures in the pediatric emergency department. Although propofol has a greater potential of respiratory depression and airway obstruction as compared with ketamine, it offers some unique advantages including a quicker offset and smoother recovery profile.

Adolescent↗

End-tidal carbon dioxide monitoring during procedural sedation.

OBJECTIVE: To prospectively determine whether end-tidal carbon dioxide (ETCO2) monitors can detect respiratory depression (RD) and the level of sedation in emergency department (ED) patients undergoing procedural sedation (PS). METHODS: This was a prospective observational study conducted in an urban county hospital of adult patients undergoing PS. Patients were monitored for vital signs, depth of sedation per the physician by the Observer's Assessment of Alertness/Sedation scale (OAA/S), pulse oximetry, and nasal-sample ETCO2 during PS. Respiratory depression was defined as an oxygen saturation <90%, an ETCO2 >50 mm Hg, or an absent ETCO2 waveform at any time during the procedure. The physician also determined whether protective airway reflexes were lost during the procedure and assisted ventilation was required, or whether there were any other complications. Rates of RD were compared with the physician assessment of airway loss and between agents using chi-square statistics. Spearman's rho analysis was used to determine whether there was a correlation between ETCO2 and the OAA/S score. RESULTS: Seventy-four patients were enrolled in the study. Forty (54.1%) received methohexital, 21 (28.4%) received propofol, ten (13.5%) received fentanyl and midazolam, and three (4.1%) received etomidate. Respiratory depression was seen in 33 (44.6%) patients, including 47.5% of patients receiving methohexital, 19% receiving propofol (p = 0.008), 80% receiving fentanyl and midazolam, and 66.6% receiving etomidate. No correlation between OAA/S and ETCO2 was detected. Eleven (14.9%) patients required assisted ventilation at some point during the procedure, all of whom met the criteria for RD. Pulse oximetry detected 11 of the 33 patients with RD. Post-hoc analysis revealed that all patients with RD had an ETCO2 >50 mm Hg, an absent waveform, or an absolute change from baseline in ETCO2 >10 mm Hg. CONCLUSIONS: There was no correlation between ETCO2 and the OAA/S score. Using the criteria of an ETCO2 >50 mm Hg, an absolute change >10 mm Hg, or an absent waveform may detect subclinical RD not detected by pulse oximetry alone. The ETCO2 may add to the safety of PS by quickly detecting hypoventilation during PS in the ED.

Adult↗

Development and implementation of an education and credentialing programme to provide safe paediatric procedural sedation in emergency departments.

OBJECTIVE: In the conduct of paediatric procedural sedation (PPS) within the ED the combination of powerful drugs, variable competency levels and high staff turnover carry the potential for sedation-associated adverse events. Yet, currently, there is no set programme for education and accreditation of ED staff in PPS. We set out to develop such a programme. METHODS: We outline the development process of a comprehensive multidisciplinary PPS programme and present its key educational elements (sedation manual, lecture, treatment order form and checklist, parent information handout) and credentialing through multiple-choice questions and competency assessments. We describe issues associated with the implementation of the programme at a metropolitan mixed ED and the ED of a major tertiary paediatric centre. RESULTS: Since its inception a total of 294 emergency staff have either completed or have partially completed the programme. Staff feedback showed that the majority of staff scored the elements of the programme as very good to excellent, and felt that their sedation skills had improved and their practice was safer. The development and implementation of the PPS programme raised many issues and posed a number of challenges. We describe the strategies we used to overcome such challenges and barriers. CONCLUSION: We present the development and implementation of a comprehensive PPS programme for emergency staff. As a result of the multicentre development process involving a community and a tertiary paediatric ED the programme will likely have broad applicability in different types of ED caring for children.

Anesthesiology↗

Propofol for procedural sedation in the pediatric emergency department.

This retrospective case series reports our experience using propofol for procedural sedation in the Emergency Department over an 18-month period with 52 pediatric patients. Propofol sedation was performed successfully in all children (mean age, 10.2 years; range 0.7-17.4 years). Indications for sedation included orthopedic manipulation, incision and drainage of abscess, sexual assault examination, laceration repair, and non-invasive imaging studies. The mean dose administered with the intermittent bolus and continuous infusion methods of delivery was 4.25 mg/kg (+/- 1.86) and 8.3 mg/kg/h, respectively. The mean recovery time was 27.1 min (+/- 15.84). No patient required assisted ventilation or developed clinically significant hypotension. Respiratory depression requiring airway repositioning or supplemental oxygen was noted in 5.8% (3/52) patients. Propofol is a reasonable alternative to facilitate sedation for a range of procedures performed in a busy Pediatric Emergency Department.

Adolescent↗

Safety and effectiveness of methohexital for procedural sedation in the emergency department.

Use of methohexital as an agent for moderate procedural sedation in the Emergency Department (ED) recently has increased. As a barbiturate, potential complications include respiratory and myocardial depression. We conducted a retrospective review of medical records and procedural flow charts for all use of methohexital in our ED during a 31-month period. We collected data on medication use, adjunctive medications, indications, procedural success, and complications. Overall, there were 114 orthopedic procedures performed using methohexital (mean dose of 1.43 mg/kg) for sedation on 104 patients. Procedures included shoulder dislocation reduction (26.3%), hip dislocation reduction (25.4%), elbow dislocation reduction (15.2%), and fracture reduction (25.4%). There was an 80.8% success rate with the first dose of methohexital. Complications occurred in 20.2% of patients and included oxygen desaturation, hypotension, hypoventilation, vomiting, tremor, and airway obstruction. All complications were transient and managed without sequelae. Use of concurrent parenteral opioid medications had no significant impact on success or complications.

Adolescent↗