PLEASE NOTE: THIS RESOLUTION WILL BE DEBATED AT THE 2015 COUNCIL MEETING. RESOLUTIONS ARE NOT OFFICIAL UNTIL ADOPTED BY THE COUNCIL AND THE BOARD OF DIRECTORS (AS APPLICABLE). RESOLUTION: 37(15) SUBMITTED BY: Pennsylvania College of Emergency Physicians SUBJECT: Intravenous Ketamine for Pain Management in the ED PURPOSE: Develop a policy statement with ENA endorsing the use of sub-dissociative ketamine as an analgesic agent and distribute the policy statement to all state nursing boards. FISCAL IMPACT: Approximately $15,000 for an in-person meeting with ENA, staff resources for initial meetings and conference calls to establish final consensus, and distributing a letter to all state nursing boards. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 WHEREAS, Symptom control, including pain management, is a prime goal of patient care in the emergency department; and WHEREAS, Alternatives to opioid analgesics may be desirable in a subset of emergency department patients; and WHEREAS, There is a growing body of evidence on the efficacy of sub-dissociative dose ketamine for analgesia in the emergency department; and WHEREAS, At sub-dissociative doses used for analgesia, ketamine is essentially devoid of the risk of clinically significant respiratory or CNS depression; and WHEREAS, While ketamine is labelled as an anesthetic, anesthesia is defined as an endpoint of medication administration and not defined by any specific agent; and WHEREAS, State nursing boards have prohibited non-CRNA nursing staff from administering low dose ketamine in the ED based on product labelling as an anesthetic; and WHEREAS, Emergency nurses routinely and safely administer other agents, such as opioids, which at higher doses may have an anesthetic effect and without specific restriction; and WHEREAS, ACEP and the Emergency Nurses Association continuously collaborate on issues that improve the delivery of emergency care; therefore be it RESOLVED, That ACEP collaborate with the Emergency Nurses Association to develop a joint position statement endorsing the use of sub-dissociative ketamine under the same procedures and policies as other analgesic agents administered by nursing staff in the emergency department setting; and be it further RESOLVED, That the position statement developed by ACEP and the Emergency Nurses Association on the use of sub-dissociative ketamine be distributed to all state nursing boards. Background This resolution asks the College to develop a policy statement with the Emergency Nurses Association endorsing the use of sub-dissociative ketamine as an analgesic agent and distribute the policy statement to all state nursing boards. Resolution 37(15) IV Ketamine for Pain Management in the ED Page 2 Ketamine is approved by the FDA as an anesthetic agent for procedures that do not require muscle relaxation. It is also approved for induction of anesthesia prior to general anesthesia and as a supplement to low-potency agents such as nitrous oxide. There has been significant controversy over the use of ketamine for procedural sedation as it creates a ‘dissociative anesthesia,’ which has been interpreted as deep sedation by some institutions. Since ketamine is labelled an anesthetic, some state boards of nursing have prohibited non-CRNA nurses from administering the medication. ACEP issued a position paper “Procedural Sedation and Analgesia in the Emergency Department: Recommendations for Physician Credentialing, Privileging and Practice” in 2011 which strongly supports emergency physicians’ administration of procedural sedation. This paper also supports the ability of nurses to administer sedatives, and specifically states they can administer propofol, ketamine, and other sedatives under the direct supervision of a privileged emergency physician. ACEP’s policy statement, “Sedation in the Emergency Department,” supports the ability of emergency physicians to administer procedural sedation. A Clinical Practice Guideline published in Annals 2011 specifically addressed the use of ketamine and supports the administration of the medication by emergency physicians. This paper also addresses sub-dissociative ketamine for analgesia, disorientation, and obtundation. CMS, in its FAQs for Revisions to Anesthesia Services Interpretive Guidelines, supports guidelines issued by national professional organizations and specifically recognizes ACEP’s Clinical Policies Subcommittee and their “Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department” in Annals of Emergency Medicine 2005, stating specifically “The Emergency Nurses Association (ENA) and the American College of Emergency Physicians (ACEP) support the delivery of medications used for procedural sedation and analgesia by credentialed emergency nurses working under the direct supervision of an emergency physician. These agents include but are not limited to etomidate, propofol, ketamine, fentanyl, and midazolam.” While these are national standards, individual states and hospitals may invoke their own limitations. Recently the drug has been used by physicians in off-label as an analgesic. There have been four small studies that demonstrate the effectiveness of low-dose ketamine for acute pain. The use of ketamine as an analgesic is offlabel. For a drug to have an on-label indication, the manufacturer must present substantial evidence to the FDA who will then consider a new indication for the drug. This is a costly endeavor for the manufacturer. Ketamine is now generic. ACEP Strategic Plan Reference Reform and Improve the Delivery System for Emergency Care Fiscal Impact Approximately $15,000 for an in-person meeting with ENA, staff resources for initial meetings and conference calls to establish final consensus, and distributing a letter to all state nursing boards. Prior Council Action Amended Resolution 29(06) Procedural Sedation adopted. The resolution directed that the existing policy “Procedural Sedation and Analgesia in the ED” be updated to state that emergency nurses are trained personnel qualified to administer all agents for procedural sedation under the direct supervision of emergency physicians. The resolution also reinforced ACEP’s opposition to other professional organizations or nursing boards restricting the supervised administration of sedating agents by emergency nurses. The policy statement is being updated by the Clinical Policies Committee. Amended Substitute Resolution 42(04) Procedural Sedation in the Emergency Department adopted. This resolution directed ACEP to work with ENA to develop a position statement regarding the administration of agents for procedural sedation/analgesia by emergency nurses, to assist state chapters and hospitals in dealing with State Boards of Nursing. Resolution 37(15) IV Ketamine for Pain Management in the ED Page 3 Amended Substitute Resolution 21(92) Procedural Sedation and Analgesia adopted. This resolution asked the Board of Directors to consider development of a clinical procedural policy on sedation and analgesia in the emergency department Prior Board Action October 2013, approved “Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department.” June 2012, rescinded the policy statement “Delivery of Agents for Procedural Sedation and Analgesia by Emergency Nurses.” This policy statement was approved by the ENA Board in March 2005 and the ACEP Board in April 2005. January 2011, approved the revised policy statement, “Sedation in the Emergency Department.” Replaced two rescinded policy statements, “Procedural Sedation in the Emergency Department” approved October 2004 and “The Use of Pediatric Sedation and Analgesia” originally approved March 1992; revised January 1997 and April 2008; and reaffirmed October 2001 Amended Resolution 29(06) “Procedural Sedation” adopted. Amended Substitute Resolution 42(04) “Procedural Sedation in the Emergency Department” adopted. April 2004, approved clinical policy “Evidence-Based Approach to Pharmacologic Agents Used in Pediatric Sedation and Analgesia in the Emergency Department.” Endorsed by the American Academy of Pediatrics (AAP), American Pediatric Surgical Association (APSA) and the Emergency Nurses Association (ENA). October 2004, rescinded the 1998 “Clinical Policy for Procedural Sedation and Analgesia in the Emergency Department.” January 1998, approved “Clinical Policy for Procedural Sedation and Analgesia in the Emergency Department.” Amended Substitute Resolution 21(92) “Procedural Sedation and Analgesia” adopted. March 1992 approved the policy statement, “The Use of Pediatric Sedation with Analgesia.” It was replaced by a policy statement with the same title in January 1997, which was reaffirmed by the Board in October 2001. Background Information Prepared by: Sandy Schneider, MD, FACEP Emergency Medicine Practice Director Reviewed By: Kevin Klauer, DO, EJD, FACEP, Speaker James Cusick, MD, FACEP, Vice Speaker Dean Wilkerson, JD, MBA, CAE, Council Secretary and Executive Director