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
  • I threw up or felt like throwing up
  • I would have the same anaesthetic again
  • I itched
  • I felt relaxed
  • I felt pain
  • I felt safe
  • I felt too hot or cold
  • I was satisfied with anaesthetic care
  • I felt pain during surgery
  • I felt good
  • I hurt
  • Disagree very much (score -3)
  • Disagree moderately (score -2)
  • Disagree slightly (score -1)
  • Agree slightly (score +1)
  • Agree moderately (score +2)
  • Agree very much (score +3)

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


Level of Evidence


Sample/Setting

Major Variables Studied and their Definitions

Intervention

Measurement

Data Analysis


and Results


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.


Limitations:

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


Level of Evidence


Sample/Setting

Major Variables Studied and their Definitions

Intervention

Measurement

Data Analysis


and Results


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

or

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 (

p

>0.05).

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

or

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.


Limitations

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


Level of Evidence


Sample/Setting

Major Variables Studied and their Definitions

Intervention

Measurement

Data Analysis


and Results


Appraisal: Worth to Practice and limitations

Citation

Design/Method


Level of Evidence


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


Level of Evidence


Sample/Setting

Major Variables Studied and their Definitions

Intervention

Measurement

Data Analysis


and Results


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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