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October, 2013

Evaluation of a Standardized Sedation Assessment in the PACU to Prevent Post-Operative Opioid-Induced Respiratory Depression. October, 2013. Paula Kobelt, MSN, RN-BC. Clinical Outcomes Manager Pain Management Karen Burke, BSN, CNSN, Pain Consult Nurse

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October, 2013

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  1. Evaluation of a Standardized Sedation Assessment in the PACU to Prevent Post-Operative Opioid-Induced Respiratory Depression October, 2013 Paula Kobelt, MSN, RN-BC. Clinical Outcomes Manager Pain Management Karen Burke, BSN, CNSN, Pain Consult Nurse Paula Renker, Ph.D.,RN, Senior Nurse Researcher Grant Medical Center

  2. Conflict of Interest Disclosure • Authors Conflicts of Interest: • Paula Kobelt, MSN, RN-BC- no conflict of interest • Karen Burke, BSN, CNSN- no conflict of interest • Paula Renker, PhD, RN- no conflict of interest

  3. Grant Medical Center, Columbus, Ohio

  4. Objectives • Identify the importance of the PACU nurse’s role in preventing post-operative opioid induced sedation and respiratory depression. • Differentiate between scales developed for purposeful/procedural sedation and those developed to assess sedation in patients receiving opioids for pain management. • Describe research strategies to evaluate the effectiveness of the POSS in the PACU. • List four outcomes found when evaluating the use of the POSS in the PACU.

  5. Every day surgical patients in hospitals nationwide routinely receive opioids in Post-Anesthesia Care Units (PACUs) to treat pain. PACU nurses are challenged daily to balance patient safety, patient satisfaction with pain management while expediting patient recovery from surgery.

  6. Opioid-Induced Respiratory Depression • Opioid-induced sedation progressing to respiratory depression is an important and serious adverse event for patients receiving opioids for pain and is estimated to occur in 0.5 to 1.2% of patients (Cashman & Dolin, 2004, Davies, et al., 2009, Fecho, Jackson, Smith, & Overdyk, 2009, Joint Commission 2012, Shapiro, Jarzyna et al., 2011). • The sequelae of opioid-induced sedation progressing to respiratory depression are well documented and include hypoxia, apnea, and respiratory arrest (American Society of Anesthesiologists, 2002, Cashman & Dolin, 2004, Considine, 2005, Davies et al., 2009, Jarzyna et al., 2011, Nisbet & Mooney-Cotter, 2009, Weinger & Lee, 2011). • The sequelae of opioid-induced sedation progressing to respiratory depression include hypoxia, apnea, and respiratory arrest (American Society of Anesthesiologists, 2002, Cashman & Dolin, 2004, Considine, 2005, Davies et al., 2009, Jarzyna et al., 2011, Nisbet & Mooney-Cotter, 2009, Weinger & Lee, 2011). • The sequelae of opioid-induced sedation progressing to respiratory depression include hypoxia, apnea, and respiratory arrest (American Society of Anesthesiologists, 2002, Cashman & Dolin, 2004, Considine, 2005, Davies et al., 2009, Jarzyna et al., 2011, Nisbet & Mooney-Cotter, 2009, Weinger & Lee, 2011).

  7. Sleep vs Sedation

  8. Background • 2012 Joint Commission's Sentinel Event Alert related to safe use of opioids in hospitals provided important information related to Opioid–related ADEs, including deaths, from their 2004-2011 data base. • 47% of the negative outcomes were attributed to wrong dose medication errors, • 29% to improper monitoring • 11% were due to excessive dosing, medication interactions and adverse effects. • The scope of the threat of opioid-induced respiratory depression is immense when you consider the number of surgeries that occur daily in most US hospitals (Pasero, 2013).

  9. Guidelines for PACU nurses

  10. Standardized Sedation Assessment • Detect incremental changes in sedation, • Facilitate nurse decision-making in safely administering opioids • Identify safe sedation levels for discharge status, • Provide a standardized language to communicate handoff information (Aubrun, Mazoit, and Riou, 2012, Nisbet & Mooney-Cotter, 2011, Pasero, 201. 2013, Pasero, Manworren, & McCaffery, 2007; Smith, 2007).

  11. 11

  12. Pasero Opioid –Induced Sedation Scale( POSS) With Interventions No revisions No revisions No revisions Unacceptable; monitor respiratory status and sedation level closely until sedation level is stable at less than 3 and respiratory status is satisfactory; immediately notify the physician to obtain an order or follow completed pre-printed orders to decrease or hold opioid dose and consider administering a non-sedating, opioid sparing nonopioid, such as acetaminophen or an NSAID, if not contraindicated Unacceptable; immediately notify they physician to obtain an order or follow completed pre-printed orders to: stop opioid; consider administering naloxone; monitor respiratory status and sedation level closely until sedation is stable at less than 3 and respiratory status is satisfactory. Modified by GMC S= Sleep, easy to arouse. Acceptable; no action necessary; may increase opioid dose if needed 1= Awake and alert. Acceptable; no action necessary; may increase opioid dose if neede  2= Slightly drowsy, easily aroused. Acceptable; no action necessary; may increase opioid dose if needed 3= Frequently drowsy, arousable, drifts off to sleep during conversation • Unacceptable; monitor respiratory status and sedation level closely until sedation level is less than 3 and respiratory status is satisfactory; decrease opioid dose 25% to 50%1 or notify prescriber2 or anesthesiologist for orders; consider administering a non-sedating, opioid-sparing nonopioid, such as acetaminophen or a NSAID, if not contraindicated. • 4=Somnolent, minimal or no response to verbal or physical stimulation • Unacceptable; stop opioid; consider administering naloxone3,4; notify prescriber2 or anesthesiologist; monitor respiratory status and sedation level closely until sedation level is stable at less than 3 and respiratory status is satisfactory. .

  13. Pasero Opioid –Induced Sedation Scale (POSS) With Interventions Pasero, C. (2013) “ If sedation and respiratory depression occur during administration of transdermal fentanyl, remove the patch; if naloxone is necessary, treatment will be needed for a prolonged period and the typical approach involves a naloxone infusion. Patient must be monitored closely for at least 24 h after discontunuation of the transdermal fentanyl.”l pg 35 S= Sleep, easy to arouse. Acceptable; no action necessary; may increase opioid dose if needed 1= Awake and alert. Acceptable; no action necessary; may increase opioid dose if neede  2= Slightly drowsy, easily aroused. Acceptable; no action necessary; may increase opioid dose if needed 3= Frequently drowsy, arousable, drifts off to sleep during conversation • Unacceptable; monitor respiratory status and sedation level closely until sedation level is less than 3 and respiratory status is satisfactory; decrease opioid dose 25% to 50%1 or notify prescriber2 or anesthesiologist for orders; consider administering a non-sedating, opioid-sparing nonopioid, such as acetaminophen or a NSAID, if not contraindicated. Ask patient to take deep breaths every 15 to 30 minutes 4=Somnolent, minimal or no response to verbal or physical stimulation Unacceptable, stop opioid, consider administering naloxone, stay with the patient, stimulate, and support respiration as indicated by the pateint status, call Rapid Response Team (Code Blue) if indicated, notify primary or anesthesia provider, monitor respiratory status and sedtion level closely until sedation level is stable at less than 3 and respiratory status is satisfactory.

  14. Purposes of the quasi-experimental study were:

  15. Methodology: 15

  16. Intervention: POSS Protocol The POSS Protocol included adding the POSS with Inteventions to the PACU “every 15 minute” assessments and before and after each opioid administration in addition to a pain rating

  17. When is best time to reassess?Opioid Dosing Guidelines Badge Backers

  18. Sample & Data Collection Strategies • Inclusion criteria included: Non-ventilated PACU patients over the age of 18 who had undergone surgery for either trauma injuries or non-trauma related scheduled joint surgeries (knee, elbow, or shoulder) and received opioid analgesia. • The sample was accrued from Grant Medical Center’s patients who met the criteria during two three-month periods; the first three months prior to implementation with the second three month period occurring one year later • Midas+TM was searched for medical records of patients with scheduled (non-trauma) orthopedic or trauma surgical procedures for the targeted time periods. • Data were entered by trained data collectors in an Access Data Base placed on a secured shared drive.

  19. Data Collection In order to evaluate the effect of the POSS, the study examined significant variables in the pre and post data collection periods.

  20. Data Collection Communication survey: • Two anonymous surveys, using 10 point rating scales, were created for PACU and post-operative unit nurses to assess their perceptions of changes associated with the implementation of the PACU POSS protocol. • Items included: level of comfort with communicating with peers, how POSS affected the quality of patient care, and confidence in administering opioids with the POSS. • Data from the surveys were entered into a SPSS data base (Version 17) for analysis.

  21. Communication Survey Sample0 (low) to 10 (high)

  22. Analysis Patient Outcomes Data from the Access data base were converted into Excel and then imported into SPSS. Participants’ records and variables were excluded if they had more than 10% missing data. Opioid medications were converted to equianalgesic doses for analysis using the Ohio Pain Initiative guidelines [ww.ohiopaininitiative.org], Admission and discharge times were changed to military time and analyzed with accommodations made for those patients being discharged after midnight. Demographic and study variables were examined using descriptive, chi-square, and paired and standard t-test analyses.

  23. Results Patient Outcomes

  24. Demographics Patient Outcomes Age & Gender GENDER: There were significantly more males (452) in the sample [t=7.964, df=833.954, p<0.001, unequal variances assumed]. The gender proportion was stable in both pre and post groups with trauma having almost twice as many males as females and the orthopedic group having slightly less than twice as many females as males.

  25. Demographics: Surgical Procedures

  26. Demographics Communication Survey

  27. Research Hypothesis H1: Adverse events that require the use of naloxone– an opioid reversal agent (antagonist) will decrease after the implementation of the POSS scale. • There were two cases (one each in the pre and post groups) of naloxone administration for patients in the study period, however, neither were related to the implementation, or lack thereof, of the POSS protocol in the PACU. • Therefore, we had insufficient data to evaluate the hypothesis.

  28. Research Hypotheses H2: The average length of stay for PACU patients in the same surgical classifications will decrease after the implementation of the POSS process as compared to the same classification of patients assessed with the Aldrete Scale during the baseline time-period. • The overall sample range of length of time spent in the PACU ranged from 30 minutes to 9.7 hours. There were no significant time differences for length of stay in the PACU for the scheduled orthopedic cases, plastic trauma, or orthopedic trauma cases.

  29. Research Hypotheses H3: PACU and post-operative unit nurses will report an overall higher perception of safe quality patient care related to opioid administration with the use and communication of the POSS protocol for sedation assessment after implementation of the POSS protocol. • Post-Surgical nurses perceptions of quality of care related to safe administration of opioid medications significantly increased from 6.76 to 7.29 on a 10 point scale (Paired t-2.985, df =44, p=.005). (higher scores indicated higher levels of quality) • Similarly, PACU nurses perception of quality of care related to safe administration of opioid medications received by PACU patients significantly increased from 7.55 to 8.59 on a 10 point scale (Paired t = -2.668, df=21, p=.014)

  30. Research Hypothesis H3(Continued) • Post-surgical unit nurses perceptions of their level of comfort in communicating with PACU nurses significantly increased from 6.80 to 7.55 on a 10 point scale (Paired t= -3.597, df=43, p= .001). Similarly, PACU level of comfort communicating with post-surgical unit clinical nurses significantly increased from 7.76 to 8.62 on a 10 point scale (Paired t=-2.257, df=20, p=.035)

  31. Research Questions Will implementation of the POSS protocol increase surgeon and anesthesia referrals or calls for assistance related to opioid administration by nurses in the PACU? • Surgeons and or Anesthesia providers were contacted 13 times (out of 842 cases) for sedation concerns (7 in the pre-intervention group and 6 in the post-intervention group). The POSS protocol did not increase calls for assistance from surgical and anesthesia personnel.

  32. Research Questions How will implementation of the POSS protocol affect the amount of opioid medication given in the PACU? • There were no significant increases or decreases in opioid administration in the patients from scheduled knee, plastic trauma, or orthopedic trauma groups.

  33. Research Questions How will implementation of the POSS protocol affect patients’ perceptions of pain while in the PACU?

  34. Research Questions Was the fidelity of the intervention maintained in the post intervention group? • Treatment fidelity describes the “faithfulness” or the extent to which the treatment was implemented according to the guidelines. Treatment fidelity in our study was demonstrated in three ways:

  35. Treatment Fidelity • The relationship between at least one POSS score documented for each dose of opioid administered in this study was 92.7% (406/445) for the entire intervention group. • Seventeen percent or 76 of the 447 medical records were randomly selected to identify if the POSS opioid administration guidelines were used appropriately when administering medications with a fidelity of 96% or 285/297 doses. • There was a 88.4% fidelity with discharge criteria and the POSS protocol (POSS score of S, 1, or 2).

  36. Conclusions • While there were relatively few surgeon and anesthesia referrals or calls for assistance related to opioid administration by nurses in the PACU for sedation concerns made in the study, introduction of the PACU POSS protocol did not increase, but decreased, number of calls needed. • Introduction of the POSS score did not change the amount of medications given nor did it increase the patient’s reports of pain experienced. • Treatment fidelity was a strength of the study; this supports the ease of use of the protocol in patient care activities. • The Pasero Opioid-Induced Sedation Scale With Interventions, similar to all clinical protocols, was initially developed from clinical and physiological parameters verified by content experts when no gold standard measure existed. Studies, such as this intervention study, strengthen the validity and reliability of the POSS With Interventions protocol for use in the PACU.

  37. Summary • In summary, the POSS protocol addresses the recommendations for a PACU systematic standardized sedation assessment from The Joint Commission and national organizations without adding additional care burdens including • 1)increasing patient length of stay in the PACU, • 2) increasing patients’ reports of experienced pain, and • 3) increasing calls for assistance or consultation from surgical and anesthesia personnel. • PACU nurses consistently implemented and documented the POSS protocol interventions appropriately in the care and monitoring of their patients. Both PACU and post-surgical unit nurses reported significant increases in their perceptions of quality of care after implementation of the protocol and PACU nurses reported significant increases in their confidence in safely administering opioids to treat pain in post-operative patients.

  38. References • Jarzyna, D., et al. (2011). American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression.Pain Management Nursing,12 (3):118-145. • Nisbet,A.T. & Mooney-Cotter, M. (2009). Comparison of selected scales for reporting opioid induced sedation. Pain Management Nursing, 10(3): 154-164. • Pasero, C. (2013) The perianesthsia nurse’s role in the prevention of opioid-related sentinel events. Journal of PeriAnesthesiaNursing48(1): 31-37 • Pasero, C & McCaffery, M. (2011). Pain Assessment and Pharmacologic Management, Mosby: St. Louis. • Pasero, C. (2009). Assessment of Sedation During Opioid Administration for Pain Management,Journal of PeriAnesthesiaNursing, 24(3): 186-190. • Shapiro A, Zohar E, Zaslansky R, et al. (2005). The frequency and timing of respiratory depression in 1524 postoperative patients treated with systemic or neuraxial morphine. Journal of Clinical Anesthesia, 17:537-42 • The Joint Commission Sentinel Event Alert: Safe use of opioids in hospitals, Issue 49, August 8, 2012, www.jointcommission.org • Weinger, M.B., & Lee, L.A. (2011). No patient shall be harmed by opioid-induced respiratory depression: Conference proceedings of “Essential monitoring strategies to Detect Clinically Significant drug-induced respiratory depression in the postoperative period”. Fall, 2011 Newsletter: Anesthesia Patient Safety Foundation.

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