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When is a patient safe for discharge after procedural sedation? The timing of adverse effect events in 1367 pediatric procedural sedations.

STUDY OBJECTIVES: The optimal timing of discharge from the emergency department (ED) after pediatric procedural sedation and analgesia has not been well studied. Because concern about delayed adverse effects commonly delays discharge after sedation, we attempted to establish the timing of adverse effects in our cohort of procedural sedations. METHODS: We analyzed data from a prospectively generated database comprising consecutive sedation events throughout a 2-year period. We determined the timing of serious (eg, hypoxia, stridor, hypotension) and other adverse effects from final medication administration and calculated adverse effect risk ratios in relation to sedation characteristics. RESULTS: In 1341 sedation events, there were 184 (13.7%) adverse effects, of which 159 (11.9%) were serious. The median age of children with and without adverse effects was similar (64 months in both groups). Most adverse effects occurred during the procedure (92%) rather than after the procedure (8%). Serious adverse effects occurred a median of 2 minutes after final medication dose (range -106 to +40 minutes). One hypoxic episode occurred each at 26, 30, and 40 minutes after final medication administration; all were repeated occurrences in children who had experienced previous hypoxia during the expected peak drug effect. CONCLUSION: Adverse effects were common; however, serious adverse effects rarely occurred after 25 minutes from the final medication administration. Those that did occur this late were all preceded by a separate similar adverse effect during the expected peak drug effect, which suggests that when similar medication regimens are used, discharge from the ED may be safe at approximately 30 minutes after final sedation medication administration if no adverse effects have occurred.

Adjuvants, Anesthesia↗

Bispectral index does not correlate with observer assessment of alertness and sedation scores during 0.5% bupivacaine epidural anesthesia with nitrous oxide sedation.

The bispectral index (BIS) has been used as a measure of the degree of sedation and level of hypnosis for IV hypnotics and sedatives, potent volatile anesthetics. We evaluated the effect of increasing concentrations of nitrous oxide (N2O) on BIS and compared it with the Observer's Assessment of Alertness and Sedation (OAA/S) scale in patients undergoing regional anesthesia. We studied 48 unpremedicated, ASA physical status I-II adult patients scheduled for lower extremity surgery under lumbar epidural anesthesia. N2O was given in oxygen to achieve measured end-tidal concentrations of 33%, 50%, and 67% N2O by a tight-fitting facemask, and each N2O concentration was maintained for 20 min. Paired measurements of BIS and OAA/S scores were obtained just before each increase in N2O concentration. Forty of the 48 subjects completed the study. Increasing N(2)O concentrations produced no changes in BIS despite a significant decrease in OAA/S scores at 50% and 67% N2O concentrations. The prediction probability for BIS and OAA/S calculated by Somers' d(x.y) were 0.60 and 0.84, respectively. Anesthesiologists should be aware that the BIS monitor may not be sensitive enough to provide an adequate measure of the depth of sedation and hypnosis when using N2O alone for sedation. It may be better to monitor sedation clinically (e.g., with the OAA/S scale) to determine the dose requirement and the adequacy of depth of sedation and hypnosis.

Adult↗

Conscious sedation clinical guideline. Conscious Sedation Working Group, Medical Association of South Africa.

OBJECTIVE: The objective of this guideline is to promote safe conscious sedation technique. OUTCOME: (I) The use of safe conscious sedation techniques with endpoints of patient comfort and anxiolysis without loss of protective reflexes; (II) the use of drugs with a wide margin of safety that will protect against unintended oversedation. EVIDENCE: Based on existing consensus statements and some research reports. VALIDATION: Relevant organisations involved in conscious sedation were asked to select a representative to participate in the MASA Conscious Sedation Working Group. All participants represented organisations. The working group met in January 1996 to consider a draft guideline. The document was amended and circulated to working group members, representative organisations and 35 interested persons for endorsement and comment using a modified Delphi technique. All respondents endorsed the guideline (with or without minor corrections.) The national organisations endorsing the guidelines are listed. RECOMMENDATIONS: The use of drugs, equipment and personnel as directed in such a way that enhances the safety of the patient. Pre-sedation screening for at-risk patients. Intra-sedation monitoring, especially the use of a pulse oximeter. Post-sedation care and discharge instructions for the patient.

Procedural Sedation↗

Sedation of difficult-to-sedate children undergoing MR imaging: value of thioridazine as an adjunct to chloral hydrate.

OBJECTIVE: The purpose of this prospective study was to evaluate the safety and efficacy of thioridazine as an adjunct to chloral hydrate sedation when children undergoing MR imaging are difficult to sedate. SUBJECTS AND METHODS: All 87 children in the study either could not be sedated with chloral hydrate alone or were mentally retarded. Thioridazine (2-4 mg/kg) was administered orally 2 hr before and chloral hydrate (50-100 mg/kg) was administered orally 30 min before the 104 MR examinations. All children were monitored by continuous pulse oximetry. All images were individually evaluated by pediatric radiologists and were graded acceptable if they contained only minimal motion artifact or no motion artifact. Studies were considered successful only when 95% or more of the images were acceptable. RESULTS: MR imaging was successful in 93 (89%) of 104 examinations. The success rate for children entered into the study because of prior failure of chloral hydrate sedation was not significantly different from the success rate for children with mental retardation. A tendency for increasing failure rate with age was not significant. No serious complications occurred during the study. The most common adverse reaction, transient reduced oxygen saturation, was seen in five children. Other adverse effects encountered were vomiting in four children, hyperactivity in two children, transient tachycardia in one child, and prolonged sedation in one child. No child required hospitalization because of an adverse reaction to sedation. CONCLUSION: The study indicates that thioridazine is a safe and effective adjunct to chloral hydrate when a child undergoing MR imaging is difficult to sedate.

Administration, Oral↗

ICU sedation after coronary artery bypass graft surgery: dexmedetomidine-based versus propofol-based sedation regimens.

OBJECTIVE: To compare dexmedetomidine-based to propofol-based sedation after coronary artery bypass graft (CABG) surgery in the intensive care unit (ICU). DESIGN: Randomized, open label. SETTING: Twenty-five centers in the United States and Canada. PARTICIPANTS: Two hundred ninety-five adults undergoing CABG surgery. INTERVENTIONS: At sternal closure, patients in group A received 1.0 microg/kg of dexmedetomidine over 20 minutes and then 0.2 to 0.7 microg/kg/h to maintain a Ramsay sedation score > or =3 during assisted ventilation and > or =2 after extubation. Patients could be given propofol for additional sedation if necessary; group B patients received propofol-based care according to each investigator's standard practice. MEASUREMENTS AND MAIN RESULTS: Mean sedation levels were within target ranges in both groups. Mean times to weaning and extubation were similar, although fewer dexmedetomidine patients remained on the ventilator beyond 8 hours. Morphine use was significantly reduced in the dexmedetomidine group. Only 28% of the dexmedetomidine patients required morphine for pain relief while ventilated versus 69% of propofol-based patients (p < 0.001). Propofol patients required 4 times the mean dose of morphine while in the ICU. Mean blood pressure increased initially in both groups, then decreased to 3 mmHg below baseline in dexmedetomidine patients; mean arterial pressure remained at 9 mmHg above baseline in propofol patients. No ventricular tachycardia occurred in the dexmedetomidine-sedated patients compared with 5% of the propofol patients (p = 0.007). Respiratory rates and blood gases were similar. Fewer dexmedetomidine patients received beta-blockers (p = 0.014), antiemetics (p = 0.015), nonsteroidal anti-inflammatory drugs (p < 0.001), epinephrine (p = 0.030), or high-dose diuretics (p < 0.001). CONCLUSION: Dexmedetomidine provided safe and effective sedation for post-CABG surgical patients and significantly reduced the use of analgesics, beta-blockers, antiemetics, epinephrine, and diuretics.

Adrenergic beta-Antagonists↗

Complications of sedation with midazolam in the intensive care unit and a comparison with other sedative regimens.

OBJECTIVE: To describe the various complications that have been reported with use of midazolam for sedation in the intensive care unit (ICU). DATA SOURCES: Publications in scientific literature. DATA EXTRACTION: Computer search of the literature. SYNTHESIS: Sedation is required in the ICU in order for patients to tolerate noxious stimuli, particularly mechanical ventilation. Under- and oversedation can lead to complications. To sedate patients in the ICU, midazolam is commonly administered via titrated, continuous infusions. Cardiorespiratory effects tend to be minimal; however, hypotension can occur in hypovolemic patients. Prolonged sedation after cessation of the midazolam infusion may be caused by altered kinetics of the drug in critically ill patients or by accumulation of active metabolites. In addition, paradoxical and psychotic reactions have been rarely reported. Tolerance and tachyphylaxis may occur, particularly with longer-term infusions (> or = 3 days). Benzodiazepine withdrawal syndrome has also been associated with high dose/long-term midazolam infusions. Compared with propofol infusions, midazolam infusions have been associated with a decreased occurrence of hypotension but a more variable time course for recovery of function after the cessation of the infusion. Lorazepam is a more cost-effective choice for long-term (> 24 hrs) sedation. CONCLUSION: Continuous infusion midazolam provides effective sedation in the ICU with few complications overall, especially when the dose is titrated.

Procedural Sedation↗

Practical oral sedation in dentistry, part I: pre-sedation consideration and preparation.

This article presents a practical approach for safe oral sedation in dentistry. When properly done, oral sedation can provide comfort and a calming treatment environment for patients whose fears inhibit them from securing needed dental care. The authors provide information on medico-legal aspects of sedation, patient treatment recommendations, counseling, evaluation, monitoring, documentation, and proper discharge procedures. The reliable sedatives that have undergone years of clinical trials with a good safety record and predictable results are presented. For each sedative drug, the description, formulation and dosage, onset, duration of sedation, Oral and side effects are discussed in a 2-part presentation.

Anesthesia, Dental↗

Practical oral sedation in dentistry. Part II--Clinical application of various oral sedatives and discussion.

This article presents a practical approach for safe oral sedation in the dental practice. When used properly, oral sedation can provide comfort and a calming treatment environment for patients whose fear inhibits them from securing needed dental care. In Part I, the authors provided information on medico-legal aspects of sedation, patient treatment recommendations, counseling, evaluation, monitoring, documentation, and proper discharge procedures. In this part, the reliable sedatives that have undergone years of clinical trials and have good records of safety and predictable results are presented. For each sedative, the description, formulation and dosage, onset, duration of sedation, and side effects are discussed.

Administration, Oral↗

A research tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale.

The need for a research tool to measure recovery from sedation was identified during the design phase of a study investigating sedative protocols following open heart surgery in children. A thorough review of the literature failed to show any scales that measure degree of sedation in children at various times after initial awakening. The Vancouver Sedative Recovery Scale (VSRS) was developed through an iterative process during which we identified numerous indicators of levels of alertness among sedated children, and then determined the applicability and face validity of these indicators. The VSRS evaluated in this study consists of 12 distinct items that encompass three categories of indicators (response; eye appearance and function; and body movement). Total possible VSRS scoring ranges from 0 to 22 (higher score indicating more alert) because some of the 12 items have more than two rating levels. The VSRS was administered to 82 pediatric intensive care unit and postanesthesia recovery patients, with each patient assessed simultaneously by at least two observers. Internal consistency as measured by Cronbach's alpha was excellent: 0.85. Interobserver agreement or reliability as measured by intraclass correlation was also very high: 0.90; and for individual items Cohen's kappa ranged from 0.65 to 0.89. We consider the VSRS to be a good beginning in our effort to quantify level of alertness after sedation in the pediatric patient population.

Anesthesia Recovery Period↗

Should the pre-sedation Glasgow Coma Scale value be used when calculating Acute Physiology and Chronic Health Evaluation scores for sedated patients? Scottish Intensive Care Society Audit Group.

OBJECTIVE: To assess the effect on the performance of Acute Physiology and Chronic Health Evaluation (APACHE) II and APACHE III of two different approaches to scoring the Glasgow Coma Scale (GCS) in sedated patients. The first approach was to assume that the GCS score was normal, and the second was to use the GCS value recorded before the patient was sedated. DESIGN: Prospective cohort study over 2 yrs. SETTING: Twenty-two general adult intensive care units in Scotland. PATIENTS: 13,291 consecutive admissions to the participating intensive care units. MEASUREMENTS AND MAIN RESULTS: After exclusion of patients according to standard, predefined criteria, the Acute Physiology and Chronic Health Evaluation II and III systems were used to calculate the probability of hospital mortality for patients included in the study. In patients whose GCS scores could not be assessed accurately during the first 24 hrs, the APACHE II and III predictions were calculated twice: first, assuming that the GCS score was normal; and second, substituting the GCS score recorded before sedation. This generated two different databases for each system, and the predictions for both were compared with the observed hospital mortality rate. The effect of the two different approaches to the GCS on the performance of both APACHE II and APACHE III was assessed using measures of discrimination (area under the receiver operating characteristic curve) and goodness of fit (calibration curves and the Hosmer-Lemeshow statistic). Analysis was undertaken for both the entire cohort and for the group of patients whose APACHE scores were altered. There was a wide variation in the number of patients who had their scores altered between participating units. There were also differences between diagnostic groups. Overall, however, 50% of the patients were sedated and 22% had their scores altered. Using the presedation GCS score increased the discrimination of both APACHE II and APACHE III. The calibration of APACHE III was also improved but that of APACHE II deteriorated. The calibration improved, however, in those patients with altered scores, suggesting that the overall deterioration is attributable to other limitations in the fit of the model to these data. Although changes had the greatest effect in patients with a neurologic or trauma diagnosis, the changes were important in most diagnostic groups. CONCLUSIONS: The GCS is an important component of both APACHE II and APACHE III. It should be assessed directly whenever possible. When patients are sedated, using the GCS score recorded before sedation is preferable to the assumption of normality. The variations between different units and different diagnostic groups highlight the possible effects of case mix on the performance of prognostic scoring systems.

APACHE↗

[Comparison of reliability of bispectral index and sedation-agitation scale in assessing the depth of sedation in patients treated with mechanical ventilation].

OBJECTIVE: To compare the reliability of bispectral index (BIS) with sedation agitation scale (SAS) in assessing the depth of sedation in ill patients on mechanical ventilation in intensive care unit (ICU). METHODS: Fifteen patients, aged 18-65 years old, who were receiving mechanical ventilation in ICU for longer than 72 hours and without brain dysfunction, were enrolled in this study. Sedatives and analgesics were suspended at 7:00 am. When patients fully woke up, propofol was infused till BIS score reaching 45-60. This was maintained for 10 minutes, then propofol dosage was decreased 10 microg . kg(-1) . min(-1) for every 10 minutes till all the drug was stopped. BIS was consecutively monitored and SAS was assessed in each interval. RESULTS: BIS score was markedly correlated with SAS (r=-0.6494, P<0.01). Although a significant correlation was still shown (r=-0.4566, P<0.01), there was wide variability in BIS scores when SAS reached 2-4. With decreasing of the propofol dosage, BIS score gradually increased. There was a satisfactory negative correlation between BIS scores and propofol dosage (r=-0.8076, P<0.01). SAS increased also following the decrease in propofol dosage, and a significant negative correlation was shown between SAS and the dosage of propofol (r=-0.6551, P<0.01). CONCLUSION: SAS is well correlated with BIS in assessing the depth of sedation in patients treated with mechanical ventilation in ICU. BIS is an objective, efficient tool for monitoring the depth of sedation in ICU critical patients who are receiving mechanical ventilation, and it is more reliable than SAS, especially when sedated levels reaching SAS 2-4.

Adult↗

Multidrug intravenous sedation: determinants of the sedative dose of midazolam.

OBJECTIVES: The efficacy of multidrug intravenous sedation regimens in oral surgery is based on the ability to titrate opioids, benzodiazepines, and barbiturates to a desired level of relaxation. Dosage requirements to reach the initial sedation end points of slurred speech and ptosis of eyelids vary widely from one patient to another. STUDY DESIGN: An assessment of physical, cardiovascular, behavioral, and pharmacologic factors that might predict midazolam dosage requirements for the initial sedation titration was carried out with data collected from a large controlled clinical trial of fentanyl, midazolam, and methohexital sedation for third molar surgery. RESULTS: Dosage requirements for the initial titration of midazolam were found to be significantly higher when fentanyl was not included in the sedation regimen and when presedation heart rate and presedation systolic blood pressure were elevated.

Adolescent↗

A prospective randomized trial comparing patient-controlled sedation using propofol and alfentanil and physician-administered sedation using diazepam and pethidine during transvaginal ultrasound-guided oocyte retrieval.

BACKGROUND: This open label study compared the effectiveness of patient-controlled sedation (PCS), with physician-administered sedation (PAS) during transvaginal ultrasound-guided oocyte retrieval (TUGOR). METHODS: A total of 106 patients was randomized using a computer model to receive either PCS (n = 51) or PAS (n = 55). Intra-operative sedation and co-operation were measured on a 5-point scale while severity of pain, and doctor and patient satisfaction were assessed using a 100 mm visual analogue scale. Number of oocytes retrieved and fertilization, cleavage and clinical pregnancy rates were also recorded. RESULTS: Levels of sedation and co-operation were similar between groups. The pain score was higher in the PCS group during (mean +/- SD, 53 +/- 23 versus 35 +/- 24; P < 0.01) and 2 h after the procedure (29 +/- 27 versus 17 +/- 22; P < 0.05). Doctors were less satisfied with PCS than PAS (62 +/- 25 versus 71 +/- 26; P < 0.05) while patients were highly satisfied with both methods (76 +/- 23 versus 74 +/- 21; not significant). There were no oversedation or peri-operative complications. Fertility outcomes were similar. Patients tended to prefer PCS when given the choice of sedation method. CONCLUSION: Although PCS provides less analgesia then PAS during TUGOR, it is safe, satisfactory and accepted by patients.

Adult↗

Choices in sedation: the balanced sedation technique.

Patients undergoing surgery under regional anaesthesia may be anxious, uncomfortable or in pain. Therefore, effective sedation throughout the procedure is an important aspect of patient management. The balanced sedation technique uses combinations of sedatives to meet the anxiolytic and analgesic needs of the individual patient. For example, benzodiazepines are effective anxiolytics, while propofol can be used to provide a suitable level of sedation, especially in patients who have expressed a wish to remain asleep during the procedure. Analgesics should be considered only in those patients who are likely to experience pain during the procedure. Basic measures to increase the comfort of the patient and to facilitate the effect of pharmacological methods include supplementary non-pharmacological techniques, for example the use of a soft mattress to prevent back pain, infusion of warmed fluids and a warm operating atmosphere. This may extend to the opportunity for patients to listen to music if they have a fear of the sounds associated with the operating room, such as technical discussions by surgical staff or the sound of surgical instruments being used and discarded. The balanced sedation technique can, therefore, help to achieve the ideal goal of a comfortable patient who is free from anxiety and pain, and can sleep if desired.

Anesthesia, Conduction↗

Patient-controlled sedation: a comparison of sedation prior to and until the end of minor oral surgery.

In order to find out whether patient-controlled sedation carried out only prior to surgery was sufficient for patients to undergo minor oral surgery, 30 patients of either sex between the ages of 16 and 30 years were selected. Each was scheduled to undergo bilateral third molar surgery, one side only at a visit. At the first visit each patient was randomly allocated to receive patient-controlled sedation with midazolam either only prior to, or to the end of surgery. At the second visit they received the alternative method of sedation when the operation was carried out on the opposite side. With both techniques the majority of the patients were relaxed and provided good operating conditions with stable vital signs and without loss of consciousness. However, when given the opportunity to sedate themselves until the end of surgery, 70 per cent obtained increments during surgery; four were assessed to have marked sedation and in five the button dropped off. When questioned at the end of both procedures, 87 per cent preferred to have increments during surgery.

Adolescent↗

Antihistamines: models to assess sedative properties, assessment of sedation, safety and other side-effects.

Behavioural changes are produced by any drug that enters the central nervous system. These psychoactive effects include changes in alertness, concentration, attention, memory, cognition, psychomotor accuracy, skilled performance and affect. Changes in psychological performance may affect the safety of both the individuals taking the drug and of those people coming into contact with them. The aims of psychopharmacological performance tests are to describe the nature, extent and severity of these changes and identify drugs without deleterious effects upon performance. Use of traditional antihistamines has until recently been associated with a number of undesirable side-effects, the most troublesome of which is sedation. There are two aspects to sedation. Firstly, an objectively determined one based on the results of psychometric tests from controlled trials and secondly, the subjects response to the administration of a drug. Although the second generation of antihistamines have a much more favourable therapeutic index, use of these agents has also been reported to cause varying degrees of sedation. As antihistamines are largely used by ambulant patients, a complete evaluation of sedation should be performed through standardized objective tests, shown to be sensitive to the central effects of antihistamines as well as reliable ratings of subjective experiences. An extensive review of the literature has identified a number of tests which appear to be sensitive to the central effects of antihistamines. These include tests of psychomotor performance, sensori-motor co-ordination speed, information processing, sensory skills as well as physiological measures and subjective rating scales. Using this battery of cognitive and psychomotor tests, it is evident that only a very limited number of antihistamines can claim to be virtually free of both objective and subjective sedative effects, although the second generation of antihistamines are generally less impairing than the original ones; when prescribed at their recommended doses.

Cognition↗

Pharmacological evidence for the involvement of alpha-2 adrenoceptors in the sedative effect of detomidine, a novel sedative-analgesic.

The sedative effect and mechanism of action of a novel imidazole derivative, detomidine, were studied in laboratory animals. Three methods were used to quantify drug-induced sedation: (i) decrease in spontaneous activity of mice; (ii) increase in barbiturate induced anaesthesia time in mice; (iii) loss of righting reflex in chicks. Clonidine and xylazine were included in the studies for comparison. The sedative potency of detomidine was shown to be approximately equal to that of clonidine and much higher than that of xylazine. In all tests, the sedative effect of detomidine was inhibited by antagonists of alpha-2 adrenoceptors (yohimbine, rauwolscine and idazoxan) but not by alpha-1 antagonists (prazosin, corynanthine). Furthermore, an ex vivo receptor binding study in the rat showed that detomidine-induced decrease in spontaneous activity was significantly correlated to [3H]clonidine but not to [3H]prazosin displacement in brain membranes. These results show that detomidine has potent sedative effects in mice, rats and chicks, and suggest that this action is mediated through stimulation of alpha-2 adrenoceptors.

Adrenergic alpha-Agonists↗

Emergency dental clinic patients in South Devon, their anxiety levels, expressed demand for treatment under sedation and suitability for management under sedation.

OBJECTIVE: To assess the anxiety levels of patients attending two salaried dental service emergency clinics, their expressed demand for treatment under sedation, and their medical suitability for dental sedation. DESIGN: A questionnaire survey, incorporating the Modified Dental Anxiety Scale (MDAS) and assessment of American Society of Anesthesiologists' (ASA) physical status classification, of all adult patients attending two emergency dental clinics in Torquay and Newton Abbot. RESULTS: 513 patients returned questionnaires. Only five declined to take part in the study. The mean MDAS for patients attending the two emergency dental clinics was 14.09 (SD 6.04) and 41.9% of patients were classified as dentally anxious (MDAS >15). A preference for treatment under sedation was expressed by 56.3%, of all patients, of whom 50.5% were classified as ASA 1 (without health problems) and would have been suitable for sedation in primary dental care. CONCLUSIONS: The reported dental anxiety levels of patients attending the two emergency dental clinics were found to be much higher than those found by previous studies in general dental practice and at dental school emergency clinics. There was a high expressed demand for treatment under sedation. Further studies are needed to assess the levels of dental anxiety seen at other dental emergency clinics and a health needs assessment to determine need as opposed to expressed demand.

Adolescent↗