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Safe and efficacious use of procedural sedation and analgesia by nonanesthesiologists in a pediatric emergency department.

BACKGROUND: Children often require relief of pain and anxiety when undergoing diagnostic or therapeutic procedures in the emergency department (ED). Procedural sedation and analgesia (PSA) has become standard practice in the outpatient setting for such procedures. Few studies have looked at the overall success and incidence of complications of PSA as performed by nonanesthesiologists. OBJECTIVES: To prospectively describe PSA as performed in a pediatric ED and to report the success of sedation and incidence of complications. DESIGN: Prospective descriptive study. Setting and Population Subjects aged 0 to 21 years presenting to the ED of an urban, tertiary care, children's hospital between May 1, 1997, and April 30, 1999, requiring PSA for a diagnostic or therapeutic procedure. METHODS: A PSA form was designed and used by ED personnel to record pertinent clinical and demographic characteristics of patients, information related to the procedure, vital signs, and occurrence of complications. Success of sedation was defined a priori as successful completion of the procedure in a minimally responsive subject. Complications were defined as apnea, hypoxia (sustained pulse oximetry, <93%), seizure, arrhythmia, laryngospasm, stridor, hypotension, rash, vomiting, disinhibition, or aspiration. Follow-up telephone calls were made to families within 24 to 48 hours of discharge from the ED to document further complications. MAIN OUTCOME MEASURES: Rate of success of sedation and incidence of complications. RESULTS: Procedural sedation and analgesia was performed 1244 times in 1215 patients during the study. The median age of the patients was 5.9 years (mean age, 6.9 years; range, 2 months to 19.4 years). There were 791 boys (65.1%) and 424 girls (34.9%). A little more than half of the patients (643 or 52.9%) required PSA for fracture reduction and 396 (32.6%) for laceration repair. Intravenous (IV) fentanyl citrate and midazolam hydrochloride was provided in 734 sedation events (59.0%); IV ketamine hydrochloride, midazolam, and atropine sulfate in 293 (23.6%); and intramuscular ketamine, midazolam, and atropine in 82 (6.6%). Procedural sedation and analgesia was successfully provided in 1177 (98.6%) of 1194 sedation events. Complications occurred in 207 (17.8%) of 1161 events. The most common complication was hypoxia (79.1% of patients), followed by vomiting (6.2% of patients). No patient required intubation. One patient had an oral airway placed, 3 patients received flumazenil, 3 patients received naloxone hydrochloride, and 1 patient received naloxone and bag-valve-mask ventilation. Seventy (9.8%) of 717 patients, following discharge from the ED, reported minor complications related to PSA. The most common complication was vomiting (76.7% of patients), followed by persistent dizziness (6.8% of patients). Patients who received IV fentanyl and midazolam were significantly more likely to experience a complication during PSA (P<.001), while patients sedated using IV ketamine, midazolam, and atropine (P =.006) or IV midazolam alone (P =.005) were less likely. No difference in success of sedation or incidence of complications at follow-up was found between the types of PSA provided. CONCLUSIONS: Complications related to PSA occurred in 17.9% of patients, but most commonly consisted of hypoxia that was easily treated. Sedation was successful in 98.6% of patients. Procedural sedation and analgesia can be safely and effectively provided by nonanesthesiologists in a pediatric ED.

Adolescent↗

Fasting and emergency department procedural sedation and analgesia: a consensus-based clinical practice advisory.

Emergency physicians frequently administer procedural sedation and analgesia to nonfasted patients; however, they currently have no specific guidelines to aid them in preprocedural risk stratification. We assembled a committee of leading emergency physician sedation researchers to develop a consensus-based clinical practice advisory for this purpose. Our goal was to create a tool to permit emergency physicians to identify prudent limits of sedation depth and timing in light of fasting status and individual patient risk factors. The advisory is not intended to assert a legal standard of practice or absolute requirement. It is expected that emergency physicians will at times appropriately deviate from it according to individualized judgment and unique clinical circumstances.

Analgesia↗

Chloral hydrate for emergent pediatric procedural sedation: a new look at an old drug.

Chloral hydrate has been time honored for pediatric procedural sedation, but its efficacy in sedation for emergency department (ED) procedures is unreported. It is hypothesized that chloral hydrate is safe and effective for ED pediatric sedation. Ninety-five consecutive children ranging from 1-10 years and requiring procedural intervention in a municipal teaching hospital ED were included in a nonrandomized controlled trial. Patients with respiratory depression, somnolence, allergy, multisystem trauma, head injury, or abdominal pain were excluded. Forty-two subjects received chloral hydrate 25 to 50 mg/kg orally at physician discretion, and 53 subjects served as controls. Cooperation with procedural completion was rated by the treating physician using the four-point sedation scoring system modified from Moody et al (1 = poor, 4 = excellent). The two groups' sedation scores were compared by the Mann Whitney U test with significance at P less than .05. Age-related subgroups of children were similarly compared. The treatment group achieved sedation score of 2.86, whereas controls had sedation score of 2.75 (P = 0.63, beta error 20% at 0.37 score difference). Subgroup analysis of children less than 6 years old (2.95 experimental versus 2.57 control) and less than 4 years old (3.00 experimental versus 2.32 control) reveals statistically significant differences (P less than .0001 and P = .01, respectively) in favor of higher sedation scores in the chloral hydrate group. Time to sedation was 42.7 minutes, time to recovery was 42.0 minutes, and no adverse drug effects were noted.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

Procedural sedation for children with special health care needs.

Children with special health care needs represent a growing percentage of pediatric patients treated in all emergency departments. Substantial literature exists concerning the medical treatment of these patients, but there is little written describing the management of procedural sedation or analgesia in this population. This article examines the unique anatomic and physiologic implications of procedural sedation or analgesia management in children with special health care needs.

Analgesia↗

Propofol for emergency department procedural sedation and analgesia: a tale of three centers.

OBJECTIVES: To characterize propofol procedural sedation and analgesia (PSA) encounters for a large patient population at multiple emergency department (ED) sites. The authors sought to assess the frequency of respiratory and cardiovascular events during propofol PSA within these settings. METHODS: This study was a prospective, descriptive series of a consecutive sample of ED patients receiving propofol for PSA at three study sites. Patients were monitored for PSA-related events, including predefined clinically relevant cardiovascular and respiratory events. Data collection was performed during PSA with a standardized data collection sheet unique to each site. RESULTS: Propofol was administered during PSA to 792 patients during the respective reporting period at each center. Indications for sedation included dislocation reduction (38%), cardioversion (10%), fracture reduction (35%), abscess incision and drainage (8%), computed tomography imaging (2%), and tube thoracostomy (1%). The cumulative rate of oxygen desaturation events for all study sites was 7.7% with a brief period of assisted ventilation with bag-valve mask in 3.9%. The cumulative rate of PSA-related hypotensive events was 3.5%. Increasing patient age and specific clinical procedure were clinical variables most associated with any propofol-related respiratory event. All PSA-related events resolved with supportive interventions during the PSA encounter. No patients required endotracheal intubation, prolonged observation, or admission for PSA-related complications. CONCLUSIONS: Propofol typically confers a deep sedation experience for ED PSA. The most common PSA events associated with propofol are respiratory related and appear consistent across these three practice settings. All propofol-related PSA events resolved with brief supportive interventions in the ED with no adverse sequelae.

Adolescent↗

Evaluation of the impact of a paediatric procedural sedation credentialing programme on quality of care.

OBJECTIVES: The aim of the present study is to describe changes in documentation, risk assessment and patient care resulting from implementation of a credentialing process for medical and nursing staff in paediatric procedural sedation (PPS) in two EDs - one an urban mixed ED and the other a specialist paediatric ED. METHODS: Chart review of 100 patients undergoing PPS prior to and 100 patients following introduction of the PPS programme. Information was extracted from medical records and sedation checklists. Demographics, drugs used, procedure performed and elements of the pre-procedural, intra-procedural and post-procedural care were compared pre- and post implementation of the PPS programme. RESULTS: Significant improvements in the post-implementation period compared with pre-implementation were seen in: frequency of documentation of informed consent (87 vs 15%, P < 0.0001); evidence of performance of a pre-procedural risk assessment (87 vs 1%, P < 0.0001); and appropriate recording of vital signs (58 vs 27%, P < 0.0001). Improvements were also noted in documentation of weight, allergies, fasting status and recording of drug orders. There were no adverse events recorded in the pre-programme period and 6 recorded in the post-programme period. CONCLUSION: The implementation of a PPS credentialing programme into these two EDs resulted in significant improvements in risk assessment, monitoring and documentation of important information related to safe PPS. These improvements should result in improved quality and safety of PPS.

Child↗

Nalmefene for elective reversal of procedural sedation in children.

Nalmefene is a newer, long-acting opioid antagonist. Its use in children for the elective reversal of emergency department procedures has not been investigated. The objective was to evaluate the safety of nalmefene in children. An open-label pediatric clinical trial was performed. The study was conducted at the emergency department of an urban, university-affiliated children's hospital and consisted of children aged 6 months to 12 years who required procedural sedation where an opioid agent was administered. Patients were excluded if there was altered mental status, history of head trauma, history of opioid allergy, or the anticipated need for opioid agents for pain relief after the procedure. At the completion of the procedure, nalmefene was administered in a dose of 0.25 microg/kg increments (max 10 microg) until sedation was resolved, or to a maximum of 1.0 microg/kg (max 40 microg). Serial ECGs, vital signs, and oxygen saturation were recorded. Sedation was assessed using the Clinical Global Impression Scale (CGIS) at baseline, 2, 4, 6, 8, and 10 minutes after the initial nalmefene dose. The observer's assessment of alertness and sedation (OAA/S) was measured at baseline, 10, 30, 60, 90, and 120 minutes after the first dose of nalmefene. Episodes of resedation were recorded. All patients received follow-up by telephone at 4 and 24 hours after the initial dose of nalmefene to identify any potential late adverse effects. Over the study interval 15 patients were enrolled. Mean age was 59.1 +/- 41.5 months. Procedures involved fracture reduction (n=8), laceration repair (n = 4), abscess drainage (n = 2), and arthrocentesis (n = 1). All patients received IV fentanyl and midazolam. The mean dosage of fentanyl and midazolam was 3.21 +/- 1.03 microg/kg and 0.07 +/- 0.03 mg/kg, respectively. The mean dose of nalmefene at the time of complete response (CGIS = 1 or 2) was 0.55 +/- 0.29 microg/kg. The median number of nalmefene doses was 2. All but one patient (93%) had a complete response based on CGIS at 10 minutes after the initial dose of nalmefene was given. Nalmefene resulted in a significant improvement in CGIS (1.60 +/- 0.82 v 3.26 +/- 0.88, P =.001) and OAA/S (median score 5 v 4) when compared at baseline with 10 minutes after the initial dose of nalmefene. Nalmefene also resulted in increased diastolic blood pressure (62.6 +/- 10.5 v 55.8 +/- 10.7, P =.04) as well as improved oxygen saturation when compared at 120 minutes to baseline (99.5 +/- 0.74% v 98.5 +/- 0.4%, P =.03). There were no significant changes in pulse, systolic blood pressure, respiratory rate, and ECG. None of the patients became resedated after nalmefene was given. One patient developed nausea and vomiting within the first 2 hours after nalmefene; this resolved without intervention before discharge. No adverse events occurred in any of the patients at 4 and 24 hours postadministration. The results of this study showed that nalmefene is effective and safe for reversal of procedural sedation by opioids in children.

Analgesics, Opioid↗

A clinical trial of propofol vs midazolam for procedural sedation in a pediatric emergency department.

OBJECTIVE: To compare the effectiveness, recovery time from sedation, and complication rate of propofol with those of midazolam when used for procedural sedation in the pediatric emergency department (PED). METHODS: A prospective, blinded, randomized, clinical trial comparing propofol and midazolam was conducted in the PED of a tertiary pediatric center. Eligible patients were aged 2-18 years with isolated extremity injuries necessitating closed reduction. All patients received morphine for pain, then were randomized to receive propofol or midazolam for sedation. Vital signs, pulse oximetry, and sedation scores were recorded prior to sedation and every 5 minutes thereafter until recovery. Recovery time, time from cast completion to discharge, and other time intervals during the PED course and all sedation-related complications were also recorded. RESULTS: Between August 1996 and October 1997, 91 patients were enrolled. Demographic data, morphine doses, and sedation scores were similar between the propofol and midazolam groups. Mean +/- SD recovery time for the propofol group was 14.9+/-11.1 minutes, compared with 76.4+/-47.5 minutes for the midazolam group, p<0.001. Mild transient hypoxemia was the most significant complication, occurring in 5 of 43 (11.6%) patients given propofol and 5 of 46 (10.9%) patients given midazolam (odds ratio 1.08, 95% CI = 0.24 to 4.76). CONCLUSION: In this study, propofol induced sedation as effectively as midazolam but with a shorter recovery time. Complication rates for propofol and midazolam were comparable, though the small study population limits the power of this comparison. Propofol may be an appropriate agent for sedation in the PED; however, further study is necessary before routine use can be recommended.

Adolescent↗

Best evidence topic report. Procedural sedation for cardioversion.

A short-cut review was conducted to establish whether any of the available drugs used for procedural sedation in patients with tachydysrhythmias are safer or more effective than the alternatives. In all, 135 papers were found using the reported searches, of which 7 presented the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these best papers are tabulated. It is concluded that propofol, methohexital, thiopentone and etomidate all seem to be good choices.

Adult↗

Is propofol safe for procedural sedation in children? A prospective evaluation of propofol versus ketamine in pediatric critical care.

OBJECTIVES: To compare propofol with ketamine sedation delivered by pediatric intensivists during painful procedures in the pediatric critical care department (PCCD). DESIGN: Prospective 15-month study. SETTING: An 18-bed multidisciplinary, university-affiliated PCCD. INTERVENTIONS: All children were randomized to the propofol or ketamine protocol according to prescheduled procedure dates. Propofol was delivered by continuous infusion after a loading bolus dose and a minidose of lidocaine (PL). Ketamine was given as a bolus injection together with midazolam and fentanyl (KMF). Repeated bolus doses of both drugs were given to achieve the desired level of anesthesia. The studied variables included procedures performed, anesthetic drug doses, procedure and recovery durations, and side effect occurrence. The patient's parents, PCCD nurse and resident physician, pediatric intensivist, and the physician performing the procedure graded the adequacy of anesthesia. MEASUREMENTS AND MAIN RESULTS: Of the 105 procedures in 98 children, PL sedation was used in 58 procedures, and KMF was used in 47. Recovery time was 23 mins for PL and 50 mins for KMF, and total PCCD monitoring was 43 mins for PL and 70 mins for KMF. Five children (10.6%) in the KMF group and in none in the PL group experienced discomfort during emergence from sedation. Transient decreases in blood pressure, partial airway obstruction, and apnea were more frequent in the PL than in the KMF sedation. All procedures were successfully completed, and no child recalled undergoing the procedure. The overall sedation adequacy score was 97% for PL and 92% for KMF (p <.05). CONCLUSIONS: Both PL and KMF anesthesia are effective in optimizing comfort in children undergoing painful procedures. PL scored better by all evaluators, recovery from PL anesthesia after procedural sedation was more rapid, total PCCD stay was shorter with PL, and emergence from PL was smoother than with KMF. Because transient respiratory depression and hypotension are associated with PL, it is considered safe only in a monitored environment (e.g., a PCCD).

Adolescent↗

Experience with procedural sedation in a pediatric burn center.

BACKGROUND: Burn care requires daily debridement, dressing changes, and assessment regarding the need for skin grafting. These procedures are painful and may require an operating room environment. METHODS: The authors reviewed their experience with 912 consecutive procedural sedations (PS) in 220 pediatric burn patients over a 2-year period to identify what influence PS had on patient care. Median patient age was 32 months, and body surface area burn was 7.2%+/-6%. Pharmacological techniques included oral and intravenous medications and N2O. The authors included all sedations given in the burn treatment area and excluded all treatments given in the intensive care unit or emergency unit. RESULTS: PS allowed for early aggressive wound debridement, virtually eliminated the need for operating room debridement (used in only 22 patients), and eliminated patient discomfort and fear often associated with subsequent debridements. Burn wound-related complications occurred in 54 patients and included wound infection (n = 18), graft loss (n = 9), and pneumonia (n = 4). The incidence of PS complications was 7% with the most common problems including decreased arterial saturation (n = 41), emesis (n = 11), and agitation (n = 8). No patient required intubation or transfer to an intensive care unit bed. The average length of stay (LOS) for all patients was 8.7+/-6.2 days, and 6.2+/-3.8 days in the 200 patients not admitted to the intensive care unit. This compares favorably with the 9.5-day LOS of patients treated in 1990. CONCLUSIONS: PS in burn patients allows for early aggressive debridement, decreases the use of the operating room for debridement, and a decrease in length of stay when compared with our previous burn patients. PS has a modest risk of complications, enhances the family's cooperation and satisfaction with health care provided, and should be an integral part of burn care in children.

Adolescent↗

Procedural sedation and analgesia in a Canadian adult tertiary care emergency department: a case series.

OBJECTIVES: To examine the safety of emergency department (ED) procedural sedation and analgesia (PSA) and the patterns of use of pharmacologic agents at a Canadian adult teaching hospital. METHODS: Retrospective analysis of the PSA records of 979 patients, treated between Aug. 1, 2004, and July 31, 2005, with descriptive statistical analysis. This represents an inclusive consecutive case series of all PSAs performed during the study period. RESULTS: Hypotension (systolic blood pressure < or = 85 mm Hg) was documented during PSA in 13 of 979 patients (1.3%; 95% confidence interval [CI] 0.3%-2.3%), and desaturation (SaO2 < or = 90) in 14 of 979 (1.4%; Cl 0.1%-2.7%). No cases of aspiration, endotracheal intubation or death were recorded. The most common medication used was fentanyl (94.0% of cases), followed by propofol (61.2%), midazolam (42.5%) and then ketamine (2.7%). The most frequently used 2-medication combinations were propofol and fentanyl (P/F) followed by midazolam and fentanyl (M/F), used with similar frequencies 58.1% (569/979) and 41.0% (401/979) respectively. There was no significant difference in the incidence of hypotension or desaturation between the P/F and M/F treated groups. In these patients, 9.1% (90/979) of patients received more than 2 different drugs. CONCLUSIONS: Adverse events during ED PSA are rare and of doubtful clinical significance. Propofol/fentanyl and midazolam/fentanyl are used safely, and at similar frequencies for ED PSA in this tertiary hospital case series. The use of ketamine for adult PSA is unusual in our facility.

Age Distribution↗

The association of preprocedural anxiety and the success of procedural sedation in children.

PURPOSE: To investigate the association between a child's preprocedural state anxiety and the success of sedation. METHODS: A consecutive sample of children aged 2 through 17 years requiring sedation for a procedure was enrolled. Pain, preprocedural anxiety (range, 0-9), and success of sedation (10=most successful) were measured. RESULTS: Fifty-nine patients were enrolled. The median age was 7 years. The median anxiety score was 1.0 (interquartile ratio, 0-3). Pain and anxiety were weakly correlated (r=.21, P>.10). The mean sedation score was 7.8 (+/-2.2). Preprocedural anxiety and successful sedation were inversely correlated (r=-0.31, P=.002). Sedation was successful in 81% of children with anxiety scores below the median and 52% with anxiety scores above the median (P=.02). Children with low anxiety were 3.8 times more likely to be successfully sedated (95% confidence interval, 1.19-12.14). CONCLUSION: Our data suggest that preprocedural state anxiety is associated with the success of sedation in children.

Adolescent↗

Ketamine for procedural sedation and analgesia by nonanesthesiologists in the field: a review for military health care providers.

Military health care providers located in field environments frequently face situations in which procedural sedation and analgesia are necessary, without the advantage of sophisticated monitoring equipment. Ketamine is a unique agent that can be administered either intravenously or intramuscularly to produce predictable and profound analgesia, with an exceptional safety profile. We review the issues unique to ketamine and provide a practical guide for the use of ketamine for adult and pediatric patients in a field environment.

Adult↗

Randomized clinical trial of propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the emergency department.

UNLABELLED: Although methohexital has been well studied for use in emergency department (ED) procedural sedation (PS), propofol has been evaluated less extensively for ED use. OBJECTIVE: The authors hypothesized that there is no difference in the depth of sedation and the rate of respiratory depression (RD) between propofol and methohexital in PS during the reduction of fractures and dislocations in the ED. METHODS: This was a randomized prospective study of nonintoxicated adult patients undergoing PS for fracture or dislocation reduction in the ED between July 2001 and March 2002. Patients were randomized to receive either propofol or methohexital, 1 mg/kg intravenously, followed by repeat boluses of 0.5 mg/kg every 2 minutes until adequate sedation was achieved. Doses, vital signs, end-tidal CO(2) (ETCO(2)) by nasal cannulae, pulse oximetry, and bispectral electroencephalogram analysis (BIS) scores were recorded. RD was defined as an ETCO(2) greater than 50 torr, an oxygen saturation less than 90% at any time, or an absent ETCO(2) waveform. After returning to baseline mental status, patients completed three 100-mm visual analog scales (VASs) regarding pain associated with the procedure, recall of the procedure, and satisfaction. RD rates and VAS outcomes were compared with chi-square tests. RESULTS: There were 109 patients enrolled; six were excluded for study protocol violations. Of the remaining 103 patients, 52 received methohexital (reduction successful in 94%) and 51 received propofol (98% successful). No cardiac rhythm abnormalities or significant decline in systolic blood pressure (>20%) was detected. Six patients required bag-valve-mask-assisted ventilations during the procedure, all for less than 1 minute; four of these patients received methohexital, and two received propofol. By the authors' definition, RD was seen in 25 of 52 (48%) patients receiving methohexital and 25 of 51 (49%) patients receiving propofol (p = 0.88). The mean minimum recorded BIS score was 66.2 (95% confidence interval [CI] = 62 to 70) for methohexital and 66 (95% CI = 60 to 71) for propofol. VAS results showed similar rates of reported pain, recall, and satisfaction for the two agents. CONCLUSIONS: The authors were unable to detect a significant difference in the level of subclinical RD or the level of sedation by BIS between the two agents. The use of either agent seems to be safe in the ED.

Adult↗

Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs.

OBJECTIVES: To compare the frequency and severity of adverse events associated with parenteral drugs commonly used for procedural sedation and analgesia (PSA) in a pediatric emergency department. METHODS: A database of consecutive patients receiving parenteral PSA was prospectively generated with the intent of monitoring safety in the emergency department. Data were logged onto a dedicated sedation sheet. A retrospective analysis was performed; comparisons were made based on sedation drugs used. RESULTS: A total of 2,609 patients from June 1, 1996, to September 16, 2003, received PSA by emergency physicians. Patients who received PSA nonparenterally (n = 109) were excluded. A total of 2,500 patients (2,279, intravenous; 221, intramuscular) remained for analysis. Age range was 19 days to 32 years (median, 6.7 years). A total of 1,511 (60.4%) were male. Four major drug combinations were identified: ketamine alone (n = 1,492; 59.7%), ketamine/midazolam (n = 299; 12.0%), midazolam/fentanyl (n = 336; 13.4%), and midazolam alone (n = 260; 10.4%). A total of 113 patients (4.5%) received various other combinations of drugs. A total of 458 adverse events were observed in 426 patients (17%). Respiratory adverse events occurred as follows: ketamine alone, 91 patients (6.1%); ketamine/midazolam, 30 patients (10%); midazolam/fentanyl, 65 patients (19.3%); midazolam alone, 15 patients (5.8%). Vomiting occurred as follows: ketamine alone, 151 patients (10.1%); ketamine/midazolam, 16 patients (5.4%); midazolam/fentanyl, six patients (1.8%); midazolam alone, two patients (0.8%). CONCLUSIONS: Drug types used in pediatric PSA are associated with different adverse event profiles. Patients receiving ketamine with or without midazolam experienced fewer respiratory adverse events but more vomiting than the commonly used combination of midazolam and fentanyl. Adverse events may occur in any patient receiving parenteral PSA.

Adolescent↗

Myoclonus associated with etomidate for ED procedural sedation and analgesia.

We report 3 cases of myoclonus associated with etomidate during ED procedural sedation and analgesia (PSA). EPs should be familiar with myoclonus associated with etomidate. Clinicians using this drug for PSA should be prepared to offer the brief period of support, and occasionally, respiratory assistance, required when etomidate-associated myoclonus is encountered.

Aged↗