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Title of Guideline (must include the word “Guideline” (not protocol, policy, procedure etc) Contact Name and Job Title (author) Dr Mark Simmonds Consultant Critical Care Medicine Elizabeth Jamieson –Advanced Pharmacist Practitioner Adult Critical Care Speciality Support (Critical Care) May 2015 Original guideline approved February 2012 Directorate & Speciality Date of submission Date on which guideline must be reviewed (this should be one to three years) Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Abstract Key Words Statement of the evidence base of the guideline – Evidence base: (1-5) 1a 1b 2a 2b 3 4 5 Guideline for the use of naloxone in adults May 2018 All patients over 16 years old: - with suspected intentional opioid overdose - in the event of unintentional respiratory depression and reduced conscious level caused by opioids. This guideline describes the use of Naloxone boluses and infusions within the clinical context of opioid overdose. Guidance is also given regarding the timing and level of observation and escalation. Naloxone, opioid, overdose, 3 meta analysis of randomised controlled trials at least one randomised controlled trial at least one well-designed controlled study without randomisation at least one other type of well-designed quasi-experimental study well –designed non-experimental descriptive studies (ie comparative / correlation and case studies) expert committee reports or opinions and / or clinical experiences of respected authorities recommended best practise based on the clinical experience of the guideline developer NUH Drugs and Therapeutics Committee David Selwyn (HoS Critical Care) Anette Freyer (Acute Medicine) Fiona Branch (Critical Care) Eleanor Crimp (Critical Care Pharmacist) Gemma George (ED Pharmacist) Navin Bedi (Consultant ED) Charlotte Bebb (Renal Consultant) For update Dr Keith Girling (Trust medical director) Consultation Process Target audience All Nursing, Medical and Pharmacy staff This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Page 1 of 8 Guideline for the use of Naloxone in adult patients Background: Naloxone is a competitive antagonist to opioid drugs and is used in the treatment of opioid overdose. Its duration of action is shorter than most opioid drugs, so close patient monitoring and repeat doses or an infusion may be required to maintain clinical effect. Naloxone will immediately reverse opioid induced respiratory depression. However, it will also antagonise the analgesic effect. Initial clinical management for suspected opioid overdose or accumulation: 1.1 Call Doctor to assess patient IMMEDIATELY if there is a: Depressed level of consciousness Neuro AVPU (alert, voice , pain, unresponsive <A) , or Respiratory Rate (Respiratory Rate (RR) ≤ 8 bpm). If occurring outside the Emergency or Critical care department the Critical Care Outreach Team (CCOT) MUST also be called 1.2 Commence Oxygen High flow oxygen (15 litres) immediately 1.3 Review Patient’s Medication All opioid medications (including opioid containing epidural infusions, and transdermal patches) should be ceased /removed immediately 1.4 Monitor Patient Once opioid overdose has been identified, patients should have: Respiratory Rate and Conscious Level (AVPU) recorded every 15 minutes. Early Warning Scores (EWS) calculated every 30 minutes. 1.5 Administer Naloxone: Immediately, once the diagnosis of opioid induced severe respiratory depression/ arrest is made. Naloxone is stock on all wards and departments where opioid drugs are used in the White Anaphylaxis and Over-sedation boxes. A patient safety incident form MUST be completed following Naloxone administration. See Quick reference guide in the box on ward or page 3 & 4 for initial doses Intravenous access should be gained as soon as possible but if delayed, intramuscular or subcutaneous doses may be given. The onset of action may be slower via these routes Initial Bolus Doses: Page 2 of 8 TWO Indications: 1. Reversal of respiratory depression and reduced conscious level from medicinal use of opioids (including post-operative use), patients receiving palliative care or are long-term (chronic) opioid users for pain control. Naloxone initially 100-200 micrograms (1.5micrograms-3micrograms/kg) as a slow IV bolus over 30 seconds with 100 micrograms repeated every 2 minutes until a satisfactory rise in respiratory rate is achieved. Prepared as 400micrograms diluted to 4ml with sodium chloride 0.9% and administered in 1ml (100microgram) aliquots. The dose should be titrated against the respiratory function and not the level of consciousness. Where possible the aim is to maintain adequate analgesia. If no IV access then naloxone 100-200 microgram boluses can be given intramuscularly or subcutaneously whilst IV access is obtained Treatment may be initiated by nursing staff in accordance with the trust wide Patient Group Direction (PGD/TW/14) for Naloxone prior to the arrival of medical staff. Caution: Use of Naloxone where it is not indicated, or in larger than these recommended doses, can cause a rapid reversal of analgesia, leading to intense pain, distress and an increase in sympathetic nervous stimulation / cytokine release precipitating acute opioid withdrawal syndrome. (See Appendix 1 and adverse effects page 6) Page 3 of 8 2. Deliberate acute opioid overdose or recreational intoxication Naloxone 400micrograms as a slow IV bolus over 30 seconds. If a response is seen to this initial dose then repeat 400 micrograms every 1-2 minutes until satisfactory respiratory rate and conscious level obtained. Each repeated dose may be given incrementally. If NO response is seen to the first dose after 60 seconds give a dose of 800 micrograms, if still NO response after a further 60 seconds repeat the dose of 800 micrograms. If still NO response give 2mg (larger doses of 4 mg maybe required in seriously poisoned patients.) If no response to total of 4mg naloxone then the diagnosis of opioid toxicity should be questioned. The dose maybe given undiluted or further diluted to 10ml with sodium chloride 0.9% If no IV access then naloxone 400microgram boluses can be given intramuscularly or subcutaneously whilst IV access if obtained. Caution: The aim is to AVOID completely reversing the effects in an opioid dependent person, as this is likely to precipitate acute withdrawal syndrome. Monitoring: In the event of adequate clinical response to naloxone (aim for RR>10 bpm, AVPU=A), observations every 15 minutes should be maintained for 2 hours. Hourly EWS should be calculated for at least 6 hours after the last dose of naloxone for immediate release preparations, 12 hours for sustained release preparations and for up to 24 hours with methadone. This maybe continued longer at the discretion of the medical team. In the event of further deterioration, further boluses of naloxone at previously therapeutic doses should be given and close patient monitoring continued. If 3 repeat boluses of naloxone are required to maintain clinical effect, transfer to a critical care area (Critical Care, City Campus or D56 MHDU or Critical Care C or E Floor, QMC Campus) should occur. A doctor Page 4 of 8 and/or CCOT nurse should remain with the patient until the patient arrives on critical care and is handed over to the critical care team. Note: Patients receiving haemodialysis on Carrel Ward who require a naloxone infusion should be discussed with Critical Care and referred to CCOT but, if deemed appropriate, may remain on Carrel Ward for ongoing renal replacement therapy. Naloxone Infusion An IV naloxone infusion may be useful where repeated IV doses are required; particularly if patients have taken opioids with a long duration of action (e.g. methadone, buprenorphine, or sustained release preparations- Morphine M/R(e.g.Zomorph) or Oxycodone MR (e.g.Longtec)). Naloxone infusions MUST NOT ideally be started or run outside of a Critical Care area, Emergency Department area 1 or Carrel Ward. If it becomes clinically necessary to start a Naloxone infusion whilst awaiting patient transfer the CCOT nurse MUST stay with the patient to monitor them. Naloxone to make the infusion should be obtained from Critical Care on both campuses, D56 medical HDU or E12 Surgical HDU, Cardiac Critical Care, ED or the pharmacy department. Infusion regimen Infusion preparation Naloxone 4mg (10 x 400 micrograms) made up to 20ml with Dextrose 5% or Sodium Chloride 0.9% (resulting solution 200 micrograms per ml). The infusion must be administered through an electronic rate controlled device (e.g. syringe pump). Preferably via a central venous catheter (or large peripheral vein) to avoid potential venous irritation due to the preparation’s low pH. Prescription The initial hourly starting rate should equal 0.6 x resuscitative cumulative bolus dose (60%) that gave an adequate clinical response. (see table1) This should then be adjusted according to clinical condition. The resuscitative dose is described as that dose that was sufficient to maintain the patient with satisfactory ventilation for at least 15 minutes. NB ~: patients may have received doses from EMAS or via the patient held Naloxone scheme, which may need to be taken into account Page 5 of 8 Table 1 Initial cumulative bolus dose producing response 400 micrograms 600 micrograms 800 micrograms 1000micrograms 1200 micrograms 1400 micrograms 1600 micrograms 1800 micrograms 2000 micrograms Initial hourly rate of naloxone likely to be necessary 240 micrograms/hr 360 micrograms/hr 480 micrograms/hr 600 micrograms/hr 720 micrograms/hr 840 micrograms/hr 960 micrograms/hr 1080 micrograms/hr 1200 micrograms/hr Rate to set pump (4mg in 20ml concentration) 1.2 ml/hr 1.8 ml/hr 2.4 ml/hr 3.0 ml/hr 3.6 ml/hr 4.2 ml/hr 4.8 ml/hr 5.4 ml/hr 6 ml/hr Further bolus doses may be required whilst titrating the infusion; in this case. Half the initial bolus dose should be given at 15 minutes into the infusion e.g: Initial cumulative bolus producing response was naloxone 800 micrograms Infusion is now set up and running at 2.4mls per hour Response is not satisfactory after 15minutes Another bolus does of 400micrograms should be given Review with medical staff after 4 hours, or prior to preparing a new infusion to determine if the infusion is still required. Adverse Effects / Symptoms of Withdrawal Abrupt reversal of opioid drugs in the context of chronic use has been reported to precipitate acute withdrawal syndrome with symptoms of restlessness, severe agitation, delirium, nausea and vomiting, sweating, shivering, abdominal pain, tachycardia, hypertension and tachypnoea. Rarely pulmonary oedema (usually in patients with pre-existing cardiac disease), arrhythmias and cardiac arrest have been reported. The possibility of pulmonary oedema should be considered particularly if there is unexpected breathlessness and hypoxia after naloxone. Page 6 of 8 Key References Electronic British National Formulary 69 http://bnf.org/bnf/bnf/62/29533.htm?q=Naloxone&t=search&ss=text&p=1 #_hit. Accessed 8th April 2015 Naloxone SPC 112th Nov 2014 (Hameln pharmaceuticals). Downloaded from http://emc.medicines.org.uk (accessed 28th January 2015) Clarke S, Dargan P, Jones A. Naloxone in Opioid Poisoning: Walking the Tightrope. EMJ 2005 22:612-16 Injectable Medicines Guide accessed via www.wales.medusa.nhs.uk on 28th January 2015 University College London Hospitals 2010. Injectable medicines administration guide 3rd Edition Toxbase http://www.toxbase.org/Poisons-Index-A-Z/NProducts/Naloxone-antidote/ accessed 8th April 2015 Trust-wide Patient Group Direction. Administration of Naloxone by registered nurses to adult patients. Feb 2015. (PGD /TW14) Nottingham University Hospitals NHS trust. Risk of distress and death from inappropriate doses of naloxone in patients on long –term opioid/opiate treatment .NHS England 20/11/2014 (Appendix 1 page 8) https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?Al ertID=102247 UK Medicines Information (UKMI). What naloxone doses should be used in adults to reverse urgently the effects of opioids or opiates? April 2015: 1-19. Available at www.evidence.nhs.uk Page 7 of 8 Appendix 1: Page 8 of 8