Patient Satisfaction and Adverse Events Related to Emergency Department Procedural Sedation
Abstract
As the pressures of operating room volumes and patient satisfaction rise, it has started to create the need to find alternate care sites or areas where procedures can be completed in a safe and timely manner. Procedural sedation and analgesia in the emergency room has become common with an ever-increasing complexity of procedures being performed. Often, the simultaneous administration of analgesics and opioids are necessary to provide both, pain relief and amnesic effects. The purpose of this review is to examine how receiving procedural sedation in the emergency department impacts patient satisfaction and adverse events. The patient satisfaction and medication side effect/adverse effects in patients receiving procedural sedation in the emergency department were examined. The results are indicative that depth of sedation, selection of patients based on ASA and cautious pre-sedation medication use improves patient satisfaction while decreasing adverse events. Even though there is personal preference of a patient’s plan of care within physician groups, emergency departments should develop and adhere to specific protocols when performing procedural sedation. A clear understanding of the need to be consistent with the plan of care must be embedded in the educational initiatives. Additionally, there the literature revealed need for future research particularly a comparative research study to quantify the patient perspective of satisfaction related to specific treatments or care plans.
Keywords:
Adverse Effects, Patient Satisfaction, Procedural Sedation, Conscious Sedation
Patient Satisfaction and Adverse Events Related to Emergency Department Procedural Sedation
Introduction
Procedural sedation and analgesia in the emergency room has become common with an ever-increasing complexity of procedures being performed. The broad principles for procedural sedation (e.g. aim, setting, staff and monitoring) are non-prescriptive and vary from emergency room to emergency room (Johnson et al., 2017). Many painful procedures are performed in the emergency department each day and require attention to pain and anxiety. To perform such procedures without the interventions required to minimize pain and anxiety for those patients would be inhumane according to Zed, Abu-Laban, Chan, & Harrison (2007). Often, the simultaneous administration of analgesics and opioids are necessary to provide both, pain relief and amnesic effects.
Emergency Room providers use several different medications for procedural sedation and analgesia, which can lead to adverse patient events. The procedural sedation medications used to control pain and provide amnestic effects can produce adverse effects such as hypotension, respiratory depression, apnea and pain on injection (Zed, et al., 2007). In patient satisfaction survey results, the perception of patients indicates that it may not be necessary to administer medications and may increase risks of adverse effects (Zed, et al. 2007). The purpose of this review is to examine how receiving procedural sedation in the emergency department impacts patient satisfaction and adverse events.
Methods
In the review of literature, the patient satisfaction and medication side effect/adverse effects in patients receiving procedural sedation in the emergency department were examined. The databases utilized were: Academic OneFile, Academic Search Premier, CINAHL Plus, Directory of Open Access Journals, Science Citation Index, SciELO, Complementary Index, Wiley Online Library Database, Education Source, Medline, Cochrane Central Register of Controlled Trials, BIOSIS Previews, and PubMed. The keywords used in the search included: Adverse Effects, Patient Satisfaction, Procedural Sedation, and Conscious Sedation.
The initial search resulted in literature that focused on types of medication used in procedural sedation and their effectiveness. Through a more advanced search included patient satisfaction measures with procedures not normally performed in the emergency department resulted in studies that aligned with the purpose of this review. These articles were varied in methodology and grouped by evidence themes. Four of the articles reviewed are Level IV Cohort studies of which three were prospective observational studies, and one was a retrospective descriptive study (Melnyk & Fineout-Overholt, 2019).
Results
With a comprehensive search of these databases, 34 articles were identified containing information relevant to adult procedural sedation in the emergency department. Twenty studies did not have patient satisfaction as an outcome, seven articles had inaccessible full text, two did not fully address the topic in discussion, and four articles were selected for this literature review. The inclusion criterion was a setting in the Emergency Department, procedural sedation administration and patient satisfaction as an outcome. The exclusion criterion was studies that lacked all three components of the inclusion criteria, inaccessible articles and those not written in the English language.
Adverse Events
Three of Four articles examined the occurrence of adverse events and patient satisfaction for patients undergoing procedural sedation in the emergency department and the fifth determined patient satisfaction alone (Zed et al., 2007; Wenzel-Smith, G., & Schweitzer, B., 2011; Smits et al., 2017; Johnson et al., 2017). Outcome data of adverse events indicated that an advanced age has a significant association to increased adverse events (Zed et al., 2007; Wenzel-Smith, & Schweitzer, 2011; Smits et al., 2017; Johnson et al., 2017). Additionally, Wenzel-Smith and Schweitzer (2011), found that opioid use in conjunction with sedative use, increased the risk of adverse events.
All four articles found there was no significant difference in rates of adverse effects based on sex of the patient. More than half of the patients had a score of ASA I, with >90% being either ASA I or ASA II (Zed et al., 2007; Wenzel-Smith & Schweitzer, 2011; Smits et al., 2017; Johnson et al., 2017). All studies report no sentinel events as an adverse event. Overall, 5.4% to 16% of patients had minimal to moderate adverse events with 6.3%-8% requiring no to minimal intervention, 1%-4.1 required moderate intervention and no patients required major medical intervention (Zed et al., 2007; Wenzel-Smith & Schweitzer, 2011; Smits et al., 2017; Johnson et al., 2017).
Patient Satisfaction
Adverse events with or without intervention and patient satisfaction with the procedure and procedural sedation are the outcomes that are used to determine efficiency, safety and patient satisfaction with procedural sedation. Two of four articles included in this review looked specifically at patient satisfaction(Zed et al., 2007; Johnson et al., 2017). A five point Likert scale was used by Zed et al. to determine patient satisfaction (see appendix A) (2017). According to Zed et al. the outcomes demonstrate a satisfied to very satisfied response of the patients who report no recall of the procedure. In their prospective observational study Johnson et al. used the Iowa Satisfaction with Anesthesia Scale (see Appendix B), a self-administered questionnaire to evaluate the level of patient satisfaction in relation to the depth of sedation (Zed et al. 2017). Patient satisfaction data was obtained from 95.7% of the patients with a median score of 2.7. Satisfaction scores ranged from 0.4 to 3.0 with patients undergoing orthopedic procedures. It was noted that patients that received pre-sedation opioids scored as the least satisfied at 2.6 with 8 orthopedic procedure patients scoring ≤ 1.0 (Zed et al. 2017).
Three of four articles discuss depth of sedation and reported 6.2% to 30% of patients had some recall of the procedure measured by either a scale such as the Brice questionnaire or by an interview of the patient (Zed et al., 2007; Smits et al., 2017; Johnson et al., 2017). According to Zed et al., (2007) & Johnson et al. (2017), the depth of sedation is correlated with patient satisfaction.
Limitations of the Evidence
Three of four articles recognize limitations to their studies. Two of the four articles mention the lack of a clear definition of a successful procedure as a limitation of the study (Zed et al., 2007; Wenzel-Smith & Schweitzer, 2011). According to Wenzel-Smith and Schweitzer (2011), a patient satisfaction questionnaire is the only way to ascertain true success of a procedure however the use of a questionnaire does not reveal the patients understanding of the question. This type of purposeful sampling allows researchers to gain particular perspectives related to their research questions (Melnyk & Fineout-Overholt, 2019). Two studies acknowledge the small sample size as their limitation (Zed et al., 2007; Wenzel-Smith & Schweitzer, 2011). Wenzel-Smith (2017), acknowledge a sample size greater than 50,000 would be needed to evaluate permanent neurological or sedation induced death events.
Discussion
Although additional research should be completed, the evidence provided in the literature validates that safety, efficiency and patient satisfaction has been demonstrated in the outcomes of the studies. The results are indicative that depth of sedation, selection of patients based on ASA and cautious pre-sedation medication use improves patient satisfaction while decreasing adverse events. According to Zed et al. (2017), using a standardized administration protocol in performing procedural sedation in the ED is associated with high patient satisfaction. Adherence to guidelines, a strong knowledge of medications and airway management are of the utmost importance in the administration of procedural sedation in the emergency room (Wenzel-Smith & Schweitzer, 2011).
Recommendations
Practice
Even though there is personal preference of a patient’s plan of care within physician groups, emergency departments should develop and adhere to specific protocols when performing procedural sedation. Utilization of consistent approach will provide the departments with consistent outcomes. These protocols should include standardized adverse event tracking and sedation and patient satisfaction scoring. These outcomes can be modified as additional data is correlated to improve patient care. Noted as a contributor of both adverse outcomes and decreased patient satisfaction, opioid usage prior to sedation should be limited as much as possible. As noted by Johnson et al. (2017), those receiving a pre-sedation opioid were significantly less satisfied as were patients receiving orthopedic procedures, half of which received pre-sedation opioids.
Education
Once protocols are introduced education that is specific to those protocols must be provided to nursing, physicians, respiratory therapists and any involved caregiver. A clear understanding of the need to be consistent with the plan of care must be embedded in the education. Patient education should include expected outcomes as well as the limited use of opioids and the expected effects of using these medications. According to Smits (2017), the lack of proper physician and nurse training can lead to serious adverse events.
Future Research
These articles were varied in methodology and grouped by evidence, the four articles reviewed are Level IV Cohort studies: three prospective observational studies, one retrospective descriptive study. (Melnyk and Fineout-Overholt, 2019). There is need for future research particularly a comparative research study that could help to quantify the patient perspective of satisfaction related to specific treatments or care plans. A comparative effectiveness trial (CET) would seek to determine which of multiple established healthcare interventions work better on selected outcomes (Melnyk and Fineout-Overholt, 2019).
References
-
Melnyk, B. M. & Fineout-Overholt, E. (2019).
Evidence-based practice in nursing & healthcare: A guide to best practice
(4
th
ed.). Philadelphia: Lippincott Williams & Wilkins. - Zed, P.J., Abu-Laban, R. B., Chan, W. W. Y., & Harrison, D. W. (2007). Efficacy, safety and patient satisfaction of propofol for procedural sedation and analgesia in the emergency department: a prospective study. Canadian Journal of Emergency Medicine, 9(6), 421-427. Retreived from: http://Search-escohost-com.exproxy.net.ucf.edu/login.aspx?direct=true&db=edswsc&AN=000207596700003&site=eds-live&scope=site
-
Wenzel-Smith, G., & Schweitzer, B. (2011). Safety and efficacy of procedural sedation and analgesia (PSA) conducted by medical officers in a level 1 hospital in Cape Town. SAMJ South African Medical Journal, 101(12), 895-898. Retrieved from
https://search-ebscohost-com.exproxy.net.uct.edu/login.apxs?direct=true&db=edswsc&AN=000299245600019&site=eds-live&scope=site
-
Smits, G., Kuypers, M., Mignot, L., Reijners, E., Oskam, E., Van Doorn, K., Thijssen, W., Korsten, E., (2017). Procedural sedation in the emergency department by Dutch emergency physicians: a prospective multicentre observational study of 1711 adults. Emergency Medical Journal
; (34)
4; p237-p242, Retrieved from:
https://emj.bmj.com/content/34/4/237
-
Johnson, O., Taylor, D., Lee, M., Ding, J., Ashok, A., Johnson, D., Weinberg, L. (2017). Patient satisfaction with procedural sedation in the emergency department.
Emergency Medicine Australasia
,
29
(3), 303–309. Retrieved from:
https://doi-org.ezproxy.net.ucf.edu/10.1111/1742-
6723.12762
Appendix A
Table 1.
Patient Satisfaction
Level of Satisfaction | No. (and %) of patients | 95% Confidence Interval (CI) |
Very Satisfied | 104 (92.0) | 85.4%-96.3% |
Satisfied | 9 (8.0) | 3.7%-14.6% |
Neutral | 0 (0.0) | NA |
Unsatisfied | 0 (0.0) | NA |
Very Unsatisfied | 0 (0.0) | NA |
NA=not applicable |
(Zed et al. 2017).
Appendix B
Table 2
Iowa Satisfaction with Anesthesia Scale Questionnaire
Scale Items | Possible responses |
|
|
Iowa Satisfaction with Anesthesia Scale (Johnson et al. 2017)
Appendix C Table 3
Evidence Table
EBP (PICOT) Question: In adult patients (P), how does receiving the procedural sedation in the emergency department (I) improve patient satisfaction (O1) and adverse events (O2)
Databases Searched: Academic OneFile, CINAHL Plus, Science Citation Index, SciELO, Wiley Online Library Database, Medline, and PubMed.
Search Terms: Fracture reduction, Conscious Sedation, Procedural Sedation Orthopedic emergency room procedures, medication adverse effects, pain, pain control, and patient satisfaction
Citation |
Design/Method
|
Sample/Setting |
Major Variables Studied and their Definitions |
Intervention |
Measurement |
Data Analysis
|
Appraisal: Worth to Practice and limitations |
Zed, P.J., Abu-Laban, R. B., Chan, W. W. Y., & Harrison, D. W. (2007). Efficacy, safety and patient satisfaction of propofol for procedural sedation and ania in the emergency department: a prospective study. Canadian Journal of Emergency Medicine, 9(6), 421-427. |
Prospectiveobservational study
Level IV |
Prospectively obtained using a standardized procedural sedation and analgesia monitoring form.
All patients receiving propofol for procedural sedation and analgesia in Vancouver General Hospital Emergency Department uring a 2-year period between December 1, 2003, and November 30, 2005. 113 Procedureal sedation and analgesia cases were compared |
Apnea= Suspension of breathing or than 30 seconds (Dependent Variable)
oxygen desaturation = SPO2 levels of less than < 90% (Dependent Variable) hypotension= absolute systolic blood pressure of < 90 mm Hg or decrease from baseline of > 20% (Dependent Variable) Procedure Type requiring sedation and analgesia = orthopedic manipulation, cardioversion, abscess , incision and drainage, chest tube insertion, Incarcerated hernia, foreign body removal sutures (Independent Variable) Patient Demographics= age in years, gender, weight in kilograms (Independent Variables) Fasting status=the time of last oral and solid intake Independent Variable) Medications used for pain control= Fentanyl, Lidocain, (Independent Variable) Medication for Sedation = Propofol (Dependent Variable) American Society of Anesthesiology (ASA) physical status classification = categorization of a patient’s physiological status to predict procedural/operative risk (Independent Variable) Depth of Sedation = Sedative effect of propofol on patient (Independent Variable) Patient satisfaction = patients perception of a positive outcome of procedure, and absence of recall of the procedure (Independent Variable) Recovery time post sedation = interval between the last dose of propofol and a recovery score of at least 7 (Box 1) as recorded on the procedural sedation and analgesia form. |
No direct intervention took place, a review of a consecutive series of 113 patient charts of patients who received propofol for procedural sedation and analgesia.
In all 113 patients the mean propofol dose administered 113 (SD 62) mg (1.6 mg/kg, SD 0.9 mg/kg). In 88 patients lidocaine was administered at a mean dose of 10.6 (SD 4.0) mg (0.15 mg/kg, SD 0.057mg/kg) In 19 patients fentanyl was administered at a mean dose of 0.11 (SD 0.06) mg (0.0015 mg/kg, SD 0.00085 mg/kg) Propofol bolus titration control 0.25-0.5 mg/kg rather the typical 1mg/kg 82% (93) of patients received supplemental oxygen during procedures |
Pre-procedure assessments included demographic information, medical history, fasting status, medications patient interview.
American Society of Anesthesiology (ASA) physical status classification All patients had continuous monitoring of heart rate, respiratory rate and oxygen saturation. A blood pressure cuff obtained measurements every 3 minutes throughout the procedure, followed by every 5 minutes for 15 minutes. The modified Ramsey sedation score, the depth of sedation was determined at baseline, throughout the procedure and until the patient returned to baseline mental status. Patients were questioned by the nurse about recall (“Do you remember the procedure?”) and asked to rate their overall satisfaction on a 5-point Likert scale. Recovery criteria score of at least 7 as recorded on the procedural sedation and analgesia form. (numeric scoring of activity, breathing, circulation, consciousness) |
Categorical data
are presented as proportions with 95% confidence intervals (CIs). Continuous data are presented as means with standard deviations (SDs). 94% (95% Cl 88%-98%) of the patients there was no recall of the procedure. All patients were very satisfied or satisfied with their procedure. No patients (0%, 95% Cl 0%-3%) had experienced apnea for more than 30 seconds Respiratory depression and apnea also appear to be dependent on dose and rate of propofol administration. 1 patient (1%, 95% Cl 0%-5%) breathing room air experienced oxygen desaturation during emesis. < 90% 9 patients (8%, 95% Cl 4%-15%) had an episode of clinically insignificant hypotension not requiring intervention. A higher incidence of hypotension has also been associated with advanced age, female sex, poor physical status and concomitant use of opioids or benzodiazepines. 7 patients (6%, 95% Cl 3%-12%) experienced pain on injection No patients experienced major adverse events. |
A lower initial 0.25-0.5 mg/kg dose of propofol is recommended
to be administered over 60 seconds, and subsequent doses dispensed at 10-20 mg/minute. Even using the total dose of 1.6mg/kg this lower starting dose can be associated with lower rates of adverse effects. Only 1 in 6 patients received fentanyl only 6.2% of patients had procedural recall, that with the high patient satisfaction rate may indicate that concomitant of analgesia with opiods may not be needed with propofol use.
As a non comparative study, this study precludes a conclusion regarding the safety and efficiency of propofol compared to other commonly used sedative medication. Small sample size may have precluded the detection of rare adverse effects. Lack of opioid administration may have led to under analgesia ion some patients. Like of follow up questioning due patient to discharge and chart review nature of study patients could not be evaluated for hyperalgesia. Physician and patient satisfaction evaluation tool was not evaluated for interrater reliability. |
Citation |
Design/Method
|
Sample/Setting |
Major Variables Studied and their Definitions |
Intervention |
Measurement |
Data Analysis
|
Appraisal: Worth to Practice and limitations |
Wenzel-Smith, G., & Schweitzer, B. (2011). Safety and efficacy of procedural sedation and analgesia (PSA) conducted by medical officers in a level 1 hospital in Cape Town. SAMJ South African Medical Journal, 101(12), 895-898. |
Retrospective descriptive study.
Level IV |
Consecutive case series with retrospective evaluation
of records of all patients requiring PSA who presented to the ED of False Bay Hospital between 1 March 2007 and 30 August 2009. 166 113 Procedureal sedation and analgesia (PSA) cases were compared |
Apnea= in this study defined as no
respiratory effort for >20 seconds; (Dependent Variable) oxygen desaturation = SPO2 levels of less than < 93% (Dependent Variable) Bradycardia= heart rate of <50 (Dependent Variable) Inadequate Sedation with or without cancellation of procedure due to failure of PSA. (Dependent variable). Vomiting and/or Nausea (Dependent variable) Hallucinations (Dependent Variable). Procedure Type requiring sedation and analgesia = orthopedic manipulation, abscess , incision and drainage, Lumbar Puncture, Retained products of conception (RPOC), sutures (Independent Variable) Patient Demographics= age in years, gender, (Independent Variables) Fasting status=the time of last oral and solid intake (Independent Variable) Alcohol intoxication. (Independent Variable) Medication for Sedation = Ketofol + midazolam ± N2O, midazolam + Ketamine ± N2O, Opiate + midazolam +
ketamine ± N2O, Single-agent midazolam ketamine, Opiate + midazolam ± N2O (Independent Variable) American Society of Anesthesiology (ASA) physical status classification = categorization of a patient’s physiological status to predict procedural/operative risk (Independent Variable) Depth of Sedation = Sedative effect of propofol on patient (Light Sedation) (Independent Variable) Patient satisfaction = patients perception of a positive outcome of procedure, and absence of recall of the procedure (Independent Variable) |
No direct intervention took place, a review of a consecutive series of 166 patient charts of patients who received procedural sedation and analgesia.
Ketofol= (Propofol 1:1 solution with ketamine), commenced at a dosage of 0.2 mg/kg for each drug and titrated to the desired effect in 2 ml increments (1 ml of the mixed solution contained 5 mg each of propofol and ketamine). Single agent Ketamine, was used at a starting dose of 0.5 mg/kg and slowly titrated in increments of 0.2 mg/kg. |
Sedation event was recorded on a standardised
anaesthetic record sheet. With the following recorded variables, age, gender, ASA status, presenting problem, fasting status, clinical impression of intoxication, PSA medications and dosages used, adverse effects, rescue manoeuvres performed, if any, and time to discharge if discharged or to other disposal of the patient Patients were monitored throughout the procedure with continuous pulse oximetry, and heart rate and blood pressure were measured before and at 2-minute intervals once procedure started. Readiness for discharge was determined in accordance with an Aldrete score of 9/10. (points for Activity, Respirations, Circulation, Consciousness, color or O2 saturation, pain, surgical bleeding (as expected), Nausea and Vomiting |
Data analysis is largely
descriptive and clinical and demographic data are presented as means (standard deviations (SDs)), medians, ranges, and proportions as appropriate. Success of sedation and incidence of adverse effects are presented as proportions. Mean age was 23 years (SD 17.98). Procedures completed in 165 (99.4%) of 166 patients. 9 (54.42%) experienced minor adverse effects. There was no statistically significant difference between
complication rates for male and female patients ( Adverse Events per Medications: Sedation = Ketofol + midazolam ± N2O resulted in 1 patient having apnea, 1/6 patients, 0% classified as light sedation midazolam + Ketamine ± N2O resulted in 1 oxygen desaturation and 1 postoperative nausea and vomiting, 2/63 patients, 4 (2.4%) classified as light sedation Opiate + midazolam + ketamine ± N2O resulted in 2 apnea, 2 desaturation, 1 Hallucination 5/34 patients 4 (2.4%) classified as light sedation
Single-agent midazolam Ketamine resulted in 1 apnea 1/50 patients 2 (1.2%) classified as light sedation Opiate + midazolam ± N2O no adverse events. 0/13 4 (2.4%) classified as light sedation Adverse Events based on Fasting status: Not Fasted, Not intoxicated 6 patients had complications (4.7%) 6/129 Not Fasted and intoxicated 1 pateint had complications (12.5%) 1/8. Fasted 2 patients had complications 6.9% 2/29. |
The intended procedures could be completed in 165 (99.4%) of 166 patients; 9 (54.42%) experienced minor adverse effects
Fasted patients had a slightly higher complication rate (6.9%) than those who had not fasted (4.7%). A trend was found towards a higher risk of complications with multi-drug regimens and addition of propofol Alcohol ingestion more than doubled the complication rate. PSA can be administered safely by MOs in district hospitals. Adherence to PSA guidelines, knowledge of drugs and basic airway management are important.
Study lacks the numbers to uncover a serious event. To assess rick of death patient numbers need to be around 50000. Rating a procedure successful is a problem in patient centered family physician approach. Rates of sedative failure reports range 3%-10-20% depending on definition used for successful sedation. A patient satisfaction questionnaire is probably the only way to ascertain true success of a procedure in a holistic, patient-centred way, and more research on PSA. |
Citation |
Design/Method
|
Sample/Setting |
Major Variables Studied and their Definitions |
Intervention |
Measurement |
Data Analysis
|
Appraisal: Worth to Practice and limitations |
Citation |
Design/Method
|
Sample/Setting |
Major Variables Studied and their Definitions |
Intervention |
Measurement |
Data Analysis and Results |
Appraisal: Worth to Practice and limitations |
Smits, Gael J. P.; Kuypers, Maybritt I.; Mignot, Lisette A. A.; Reijners, Eef P. J.; Oskam, Erick; Van Doorn, Karen; Thijssen, Wendy A. M. H.; Korsten, Erik H. M.. (2017), Procedural sedation in the emergency department by Dutch emergency physicians: a prospective multicentre observational study of 1711 adults. Emergency Medical Journal ; (34) 4; p237-p242 |
Prospective observational study
Level IV |
Adult patients undergoing procedural sedation by EPs or EM residents in eight hospitals in the Netherlands (seven community hospitals (of which six are EM teaching hospitals) and one academic medical centre) from 2006 to 2013 and included 1711 adult patients having undergone Procedureal Sedation and Analgesic (PSA) were compared
Only patients American Society of Anesthesiologists (ASA) class I–III patients were eligible for PSA by non-anaesthesiologists |
Patients aged 17 and older were included.
(Dependent Variable). Patient Demographics= age in years, gender, (Independent Variables) Fasting status=the time of last oral and solid intake (Independent Variable) ASA Class (Dependent Variable). Opioid or Esketamine Coanalgesia (Independent Variable). American Society of Anesthesiology (ASA) physical status classification = categorization of a patient’s physiological status to predict procedural/operative risk (Independent Variable). Adverse Effects: Agitation, Emesis, Emergence phenomena, Hypotension, Hypoxia,Tachycardia subcutaneous injection of sedative, Airway obstruction Apnea Hypoxia Hypotension (Dependent Variable). Level of Provider training= (79.7%) were sedated by an EP, and the remainder by an EM resident Dissociation= disconnecting from one’s thoughts, feelings, memories or sense of identity. |
No direct intervention took place, a review of a consecutive series of 1711 patient charts of patients who received procedural sedation and analgesia.
Sedative medication and average dosage: Propofol = 1.1mg/kg midazolam=0.06 mg/kg, and Esketamine Discharge criteria were level of consciousness as before sedation, able to eat and drink, no nausea, pain well under control, vital signs stable (breathing, circulation), and a minimum of 2 hours after administration of a reversal agent. |
Preprocedural screening was performed using a standardised PSA registration form. Information recorded included ASA classification, medical history, allergies, height and weight, expected airway difficulties and fasting state. Vitals signs were measured at regular intervals, during and after the procedure, until the patient was fully awake.
Vitals signs were measured at regular intervals, during and after the procedure, until the patient was fully awake. The measurements included BP, RR, pulse oximetry and HR. ECG monitoring was included in most patients as well. Except for one hospital, end-tidal CO2. Depth of sedation was registered using ASA levels of sedation for non-esketamine sedations. One hospital used Ramsay scale instead of ASA. Post PSA, physicians registered the deepest level of sedation, amnesia, pain ratings with the verbal numerical rating scale. World SIVA adverse sedation reporting tool was applied in retrospect. |
Data were analysed with SPSS V.19.
Continuous variables were presented as means (95% CIs) or medians (IQR; min–max) depending on normal distribution of the data. Categorical variables were presented as percentages. median age was 59 years (min–max 17–100 years), with 41.8% aged 65 and older. of 1711 adults undergoing procedural sedation by EPs, we found adverse events in 10.6% of patients. Propofol was associated with a significant shorter duration of sedation (p<0.001) when compared with esketamine or midazolam. Ramsay sedation scale, sedation depth was registered in 206 of 267 cases, with 38.9% having a scale of 4 or 5 (brisk or sluggish response to a light glabellar tap or to verbal stimulus) and no one with a scale of 6 (no response). Dissociation scoring was registered in 71 of 129 esketamine cases with 77.5% of 71 patients being dissociated. No statistical difference in adverse event rate between propofol, midazolam and esketamine. Overall procedural success rate of 90% lower than previous studies (95-96),, may due to type of procedure due to higher failure rates. 7.7% absolute difference in success rate in favour of EPs compared with EM residents indicating level of training Propofol was associated with better procedural success rates than midazolam, Propofol and esketamine had similar success rates lower sedation levels in our cohort (ASA sedation level minimal 16%, moderate 47%), may have resulted in a lower Amnesia effect, 83% of patients. |
Procedural sedation in countries new to the procedure appears safe when performed by EPs and trained EM residents with comparable Adverse Effect rates.
Using Paper data may have led to to missing data for some variables. During the study there was no mandatory registration of PSA, therefore all cases may not have been captured. Possible omission of data regarding amnesia if omitted by physician if patient was not amnestic. One hospital uses Ramsey Sedation Scoring rather than ASA criteria. Siva Scoring proposed in 2012, tool applied retrospectively |
Citation |
Design/Method
|
Sample/Setting |
Major Variables Studied and their Definitions |
Intervention |
Measurement |
Data Analysis
|
Appraisal: Worth to Practice and limitations |
Johnson, O. G., Taylor, D. M., Lee, M., Ding, J.-L., Ashok, A., Johnson, D., Weinberg, L. (2017). Patient satisfaction with procedural sedation in the emergency department. Emergency Medicine Australasia , 29 (3), 303–309. |
Prospective
Observational study Level IV |
Urban adult/paediatric, tertiary
referral ED and an inner city, adult-only, tertiary referral ED There were two data collection periods, determined by the availability of research staff: July 2007 to October 2008 and February 2015 to June of 2015 (total 20 months). Inclusion criteria were age 16 years or older. Exclusion criteria were medical rea- sons (major injury, ongoing pain or discomfort) or communication difficulties (poor English, cognitive impairment). |
Type of Procedure=Orthopaedic or Cardioversion
Intercostal catheter insertion Foreign body removal Incision and drainage Or Other (dependent Variable) Pre-sedation opioids= any opioid given prior o procedure. (independent Variable). Sedation Medication regimens Medications ordered. (Independent variable) Consultant designation= consultant or other practitioner (Independent Variable) Depth of Sedation = Sedative effect of propofol on patient (Light Sedation) (Independent Variable) Patient satisfaction = patients perception of a positive outcome of procedure, and absence of recall of the procedure (Independent Variable) |
Patients administered nitrous oxide
to facilitate a digital ring block. The drug regimens given to patients propofol/fentanyl (two patients), nitrou s oxide only (two), propofol only (one), ketafol (ketamine/ propofol combination, one), ketamine only (one), midazolam only (one) and nitrous oxide/fentanyl (one). |
Investigator observed all proce-
dures and recorded patient demo- graphics, the nature and outcome of the procedure, the sedation drugs regimen, the maximum depth of sedation and adverse events Depth of sedation was measured using the Observers Assessment of Anaesthesia/Sedation Scale (OAAS) Patient satisfaction was measured using the Iowa Satisfaction with Anaesthesia Scale (ISAS) |
Satisfaction was high among
patients with no memory of the operation but lower among patients who had recall of pain or being awake and unable to communicate. Five patients had sedation scores of 6 and single patients had scores of 5, 4, 3 and 2. Their median (IQR) and mean (SD) sedation scores were 6 (2) and 4.9 (1.5), respectively. Procedures were short with a median (IQR) time from induction until wakening of 8 (8) min. The median (IQR) time from completion of the procedure until wakening was 3 (3.25) min. Patient satisfaction data were obtained from 156 (95.7%) patients. Overall, the median (IQR) satisfac- tion score was 2.7 (0.7) but ranged from −0.4 to 3.0. Patients who had an orthopaedic procedure were administered a pre-sedation opioid (92 [80%] vs 5 [10.4%], difference in proportions 69.6% (95% confidence interval 56.8– 82.4, P < 0.001). Patient satisfaction correlated posi- tively with depth of sedation: Spearman’s correlation coefficient 0.49 (P< 0.001) Satisfaction was greatest among patients administered propofol with or without fentanyl and least among those administered nitrous oxide with or without opioid |
Satisfaction was high among
patients with no memory of the operation but lower among patients who had recall of pain or being awake and unable to communicate Most patients reported no memory of the procedure Patients having an orthopaedic procedure are at risk of being less satisfied. Orthopaedic injuries and procedures can be very painful and it is not surprising that the large majority of these patients were administered a pre-sedation opioid. Nine patients had low satisfaction scores, eight of nine had orthopediac procedures, and four were administered propofol. Five had sedation scores of six, but confounding variables impacted satisfaction, for example the quality of preprocedure analgesia. Maximise the chance of a positive experi- ence for the patient, deep sedation is required. The depth of sedation did not differ between patients who were and were not sedated by a consultant. |
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