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      Incidence of Adverse Events in Adults Undergoing Procedural Sedation in the Emergency Department: A Systematic Review and Meta‐analysis

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          Abstract

          Objectives

          This was a systematic review and meta‐analysis to evaluate the incidence of adverse events in adults undergoing procedural sedation in the emergency department ( ED).

          Methods

          Eight electronic databases were searched, including MEDLINE, EMBASE, EBSCO, CINAHL, CENTRAL, Cochrane Database of Systematic Reviews, Web of Science, and Scopus, from January 2005 through 2015. Randomized controlled trials and observational studies of adults undergoing procedural sedation in the ED that reported a priori selected outcomes and adverse events were included. Meta‐analysis was performed using a random‐effects model and reported as incidence rates with 95% confidence intervals ( CIs).

          Results

          The search yielded 2,046 titles for review. Fifty‐five articles were eligible, including 9,652 procedural sedations. The most common adverse event was hypoxia, with an incidence of 40.2 per 1,000 sedations (95% CI = 32.5 to 47.9), followed by vomiting with 16.4 per 1,000 sedations (95% CI = 9.7 to 23.0) and hypotension with 15.2 per 1,000 sedations (95% CI = 10.7 to 19.7). Severe adverse events requiring emergent medical intervention were rare, with one case of aspiration in 2,370 sedations (1.2 per 1,000), one case of laryngospasm in 883 sedations (4.2 per 1,000), and two intubations in 3,636 sedations (1.6 per 1,000). The incidence of agitation and vomiting were higher with ketamine (164.1 per 1,000 and 170.0 per 1,000, respectively). Apnea was more frequent with midazolam (51.4 per 1,000), and hypoxia was less frequent in patients who received ketamine/propofol compared to other combinations. The case of laryngospasm was in a patient who received ketamine, and the aspiration and intubations were in patients who received propofol. When propofol and ketamine are combined, the incidences of agitation, apnea, hypoxia, bradycardia, hypotension, and vomiting were lower compared to each medication separately.

          Conclusions

          Serious adverse events during procedural sedation like laryngospasm, aspiration, and intubation are exceedingly rare. Quantitative risk estimates are provided to facilitate shared decision‐making, risk communication, and informed consent.

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          Most cited references69

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          Practice guidelines for sedation and analgesia by non-anesthesiologists.

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            A prospective evaluation of "ketofol" (ketamine/propofol combination) for procedural sedation and analgesia in the emergency department.

            We evaluate the effectiveness and consider the safety of intravenous ketamine/propofol combination ("ketofol") in the same syringe for procedural sedation and analgesia in the emergency department (ED). A prospective case series of consecutive ketofol procedural sedation and analgesia events in the ED of a trauma-receiving community teaching hospital from July 2005 to February 2006 was studied. Patients of all ages, with any comorbid conditions, were included. Ketofol (1:1 mixture of ketamine 10 mg/mL and propofol 10 mg/mL) was administered intravenously at the discretion of the treating physician by using titrated aliquots. The presence or absence of adverse events was documented, as were procedural success, recovery time, and physician, nurse, and patient satisfaction. Physiologic data were recorded with established hospital procedural sedation and analgesia guidelines. One hundred fourteen procedural sedation and analgesia events using ketofol were performed for primarily orthopedic procedures. The median dose of medication administered was ketamine at 0.75 mg/kg and propofol at 0.75 mg/kg (range 0.2 to 2.05 mg/kg each of propofol and ketamine; interquartile range [IQR] 0.6 to 1.0 mg/kg). Procedures were successfully performed without adjunctive sedatives in 110 (96.5%) patients. Three patients (2.6%; 95% confidence interval [CI] 0.6% to 7.5%) had transient hypoxia; of these, 1 (0.9%; 95% CI 0.02% to 4.8%) required bag-valve-mask ventilation. Four patients (3.5%; 95% CI 1.0% to 8.7%) required repositioning for airway malalignment, 4 patients (3.5%; 95% CI 1.0% to 8.7%) required adjunctive medication for sedation, and 3 patients (2.6%; 95% CI 0.6% to 7.5%) had mild unpleasant emergence, of whom 1 (0.9%; 95% CI 0.02% to 4.8%) received midazolam. No patient had hypotension or vomiting or received endotracheal intubation. Median recovery time was 15 minutes (range 5 to 45 minutes; IQR 12 to 19 minutes). Median physician, nurse, and patient satisfaction scores were 10 on a 1-to-10 scale. Ketofol procedural sedation and analgesia is effective and appears to be safe for painful procedures in the ED. Few adverse events occurred and were either self-limited or responded to minimal interventions. Recoveries were rapid, and staff and patients were highly satisfied.
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              Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial.

              Investigative efforts to improve monitoring during sedation for patients of all ages are part of a national agenda for patient safety. According to the Institute of Medicine, recent technological advances in patient monitoring have contributed to substantially decreased mortality for people receiving general anesthesia in operating room settings. Patient safety has not been similarly targeted for the several million children annually in the United States who receive moderate sedation without endotracheal intubation. Critical event analyses have documented that hypoxemia secondary to depressed respiratory activity is a principal risk factor for near misses and death in this population. Current guidelines for monitoring patient safety during moderate sedation in children call for continuous pulse oximetry and visual assessment, which may not detect alveolar hypoventilation until arterial oxygen desaturation has occurred. Microstream capnography may provide an "early warning system" by generating real-time waveforms of respiratory activity in nonintubated patients. The aim of this study was to determine whether intervention based on capnography indications of alveolar hypoventilation reduces the incidence of arterial oxygen desaturation in nonintubated children receiving moderate sedation for nonsurgical procedures. We included 163 children undergoing 174 elective gastrointestinal procedures with moderate sedation in a pediatric endoscopy unit in a randomized, controlled trial. All of the patients received routine care, including 2-L supplemental oxygen via nasal cannula. Investigators, patients, and endoscopy staff were blinded to additional capnography monitoring. In the intervention arm, trained independent observers signaled to clinical staff if capnograms indicated alveolar hypoventilation for >15 seconds. In the control arm, observers signaled if capnograms indicated alveolar hypoventilation for >60 seconds. Endoscopy nurses responded to signals in both arms by encouraging patients to breathe deeply, even if routine patient monitoring did not indicate a change in respiratory status. Our primary outcome measure was patient arterial oxygen desaturation defined as a pulse oximetry reading of 5 seconds. Secondary outcome measures included documented assessments of abnormal ventilation, termination of the procedure secondary to concerns for patient safety, as well as other more rare adverse events including need for bag-mask ventilation, sedation reversal, or seizures. Children randomly assigned to the intervention arm were significantly less likely to experience arterial oxygen desaturation than children in the control arm. Two study patients had documented adverse events, with no procedures terminated for patient safety concerns. Intervention and control patients did not differ in baseline characteristics. Endoscopy staff documented poor ventilation in 3% of all procedures and no apnea. Capnography indicated alveolar hypoventilation during 56% of procedures and apnea during 24%. We found no change in magnitude or statistical significance of the intervention effect when we adjusted the analysis for age, sedative dose, or other covariates. The results of this controlled effectiveness trial support routine use of microstream capnography to detect alveolar hypoventilation and reduce hypoxemia during procedural sedation in children. In addition, capnography allowed early detection of arterial oxygen desaturation because of alveolar hypoventilation in the presence of supplemental oxygen. The current standard of care for monitoring all patients receiving sedation relies overtly on pulse oximetry, which does not measure ventilation. Most medical societies and regulatory organizations consider moderate sedation to be safe but also acknowledge serious associated risks, including suboptimal ventilation, airway obstruction, apnea, hypoxemia, hypoxia, and cardiopulmonary arrest. The results of this controlled trial suggest that microstream capnography improves the current standard of care for monitoring sedated children by allowing early detection of respiratory compromise, prompting intervention to minimize hypoxemia. Integrating capnography into patient monitoring protocols may ultimately improve the safety of nonintubated patients receiving moderate sedation.
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                Author and article information

                Journal
                Acad Emerg Med
                Acad Emerg Med
                10.1111/(ISSN)1553-2712
                ACEM
                Academic Emergency Medicine
                John Wiley and Sons Inc. (Hoboken )
                1069-6563
                1553-2712
                22 January 2016
                February 2016
                : 23
                : 2 ( doiID: 10.1111/acem.2016.23.issue-2 )
                : 119-134
                Affiliations
                [ 1 ] Department of Emergency MedicineMayo Clinic Rochester MN
                [ 2 ] Division of Preventive, Occupational, and Aerospace MedicineMayo Clinic Rochester MN
                [ 3 ] Mayo Medical LibraryMayo Clinic Rochester MN
                [ 4 ] Kern Center for the Science of Health Care DeliveryMayo Clinic Rochester MN
                [ 5 ] Department of Emergency MedicineUniversity of Minnesota Medical School Minneapolis MN
                [ 6 ] Department of Emergency MedicineHennepin County Medical Center Minneapolis MN
                Author notes
                [*] [* ]Address for correspondence and reprints: M. Fernanda Bellolio, MD, MS; Bellolio.Fernanda@ 123456mayo.edu .
                Article
                ACEM12875
                10.1111/acem.12875
                4755157
                26801209
                eba2751c-54fc-41fe-88e0-5456580daffb
                © 2016 The Authors. Academic Emergency Medicine published by Wiley Periodicals, Inc. on behalf of Society for Academic Emergency Medicine

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 06 May 2015
                : 27 July 2015
                : 25 August 2015
                : 27 August 2015
                Page count
                Pages: 16
                Categories
                Progressive Clinical Practice
                Progressive Clinical Practice
                Custom metadata
                2.0
                acem12875
                February 2016
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.7.6 mode:remove_FC converted:10.02.2016

                Emergency medicine & Trauma
                Emergency medicine & Trauma

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