HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 1 of 8 APPROVED BY: PURPOSE: 1. To provide guidelines for the utilization of Nurse Administered Nitrous Oxide in Radiology/Imaging Services for an identified patient population. Nitrous Oxide is used to achieve a state of minimal sedation for the purpose of completing painful or anxiolytic procedures with reduced psychological distress and in a discomfort free state for the procedure completion. 2. Patient population – There is not a contraindication based on age. Use of Nitrous Oxide/Oxygen (N2O/O2) is most beneficial to the child with a chronologic or developmental age 1- 13. 3. Procedures that are short in duration – less than 45 minutes and can cause anxiety, lack of cooperation or pain/discomfort. This includes bladder catheter insertion, Barium enema, PIV placement, and GJ tube replacement. STATEMENT: 1. Radiology Nursing with oversight from CHLA Department of Anesthesiology Critical Care Medicine (ACCM) has established the following guidelines for the administration of Nitrous Oxide up to 70% concentration for the purpose of providing minimal sedation and anxiolysis for procedures done in the radiology department. 2. A RN providing N2O/O2 via mask inhalation will have received instruction with documentation and demonstration of clinical competency in the administration and monitoring of N2O/O2. This is followed by annual validation of continuous competency. (See Appendix 1) 3. An Anesthesiologist, though not directly responsible for the care of the patient, is aware that a patient is receiving N2O/O2 and is immediately available any time N2O/O2 inhalation is delivered. 4. N2O/O2 inhalation, as referred to in this policy, is not used in combination with any medication intended to produce sedation or opioid related medication other than Midazolam. N2O/O2 cannot be given if patient has received an opioid or sedative other than Midazolam in the past 6 hours prior to planned administration. Midazolam may be given orally within 4 hours prior to the N2O/O2 administration with a limit of no more than 1mg per kg. 5. N2O/O2 inhalation will only be administered via appropriate, approved delivery devices for which the administrating nurse has been explicitly trained. DEFINITION: Analgesic: an agent that relieves pain and may or may not alter level of consciousness. Anxiolytic: preventing or reducing anxiety, an antianxiety medication which may also produce sedation ASA Scoring A standardized method of scoring physical status for sedation or anesthesia ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 2 of 8 APPROVED BY: ASA IV A patient with severe systemic disease that is a constant threat to life Fail Safe Mechanism: built in mechanism of the Nitrous Oxide delivery unit that automatically prevents the flow of nitrous oxide if oxygen flow is terminated, thus ensuring oxygen delivery at a minimum of 30% at all times to patients receiving nitrous oxide oxygen sedation. Minimal Sedation is a drug induced state of relaxation, calmness and amelioration of fears associated with (1) maintenance of protective reflexes, (2) maintenance of a patent airway, (3) ability to respond to verbal command, (4) maintenance of spontaneous ventilation and normal cardiovascular function, and (5) possible impaired cognitive function and coordination. Nitrous Oxide is a colorless, sweet-smelling gas with anxiolytic, amnesic and mild to moderate analgesic properties. Onset and recovery are rapid, within 5 minutes. It is relatively insoluble, with rapid equilibrium between alveolus and capillaries. It crosses the blood-brain barrier easily. Patient remains awake with protective cough and gag reflect intact. Provides a comfortable and relaxed state, while patient remains aware of surroundings and able to follow commands. Nitrous Oxide/Oxygen (N2O/O2) Titration is a method of administering a drug (N20) to a specific level or endpoint of sedation. Scavenging system is used to collect and remove vented anesthetic gases from procedural use. Collects waste anesthesia gases as the patient exhales. Goals of Nitrous Oxide Use: 1. Provide age appropriate preparation for procedures in the imaging and radiology department 2. Achieve a level of analgesia, anxiolysis and amnesia for the procedure to be completed in a therapeutic manner 3. Decrease agitation and improve cooperation 4. Provide for rapid recovery and safe discharge 5. Facilitate technical performance of the procedure Patient Selection 1. Candidates for N2O/O2 are those patients that are either anxious or unable to cooperate by holding still for a somewhat painful or anxiety producing procedure. 2. ASA I and II 3. Mouth or Nose breather 4. Procedure of limited duration that is either anxiety producing or causes a low level pain or discomfort 5. NPO status 2 hours prior to procedure is recommended but not required Contraindications for using Nitrous Oxide/Oxygen 1. Patient with any condition where air may be trapped in the body, including: Maxillofacial injuries with the potential for trapped gas Recent middle ear occlusion (e.g., tympanoplasty) Severe bullous emphysema (e.g., cautions with patients with cystic fibrosis) Recent (6 weeks) Intraocular surgery HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 3 of 8 APPROVED BY: Pneumothorax Intestinal Obstruction 2. Within 3 weeks of a craniotomy 3. Intracranial hypertension 4. Pregnancy 5. Vitamin B12 deficiency 6. History of bleomycin administration 7. Impaired level of consciousness 8. Intoxication with drugs or alcohol 9. Taking psychotropic drugs 10. Anyone including providers, employees, and family members of the patients or visitors who is pregnant is not to be present during nitrous oxide administration. Staff Qualifications: 1. Licensed Independent Practitioner (Provider) is qualified to order N2O/O after completion of initial education (Appendix 1) and has ongoing competency on file with the medical staff office. 2. RNs that have demonstrated competency with use of the equipment and procedure for pediatric sedation and N2O/O2 administration may administer up to a 70% Nitrous Oxide/30% Oxygen via mask with an order from an authorized Licensed Independent Practitioner. 3. Initial Instruction is a combination of didactic and skill demonstration with annual re-validation of skills. (Appendix 1) 4. The RN is required to have the same knowledge and skills in administering medications to induce sedation as for any other medications the nurse administers. This knowledge base includes, but is not limited to: the effects of the medication, contraindications for the administration of the medication, and the amount of medication to be administered, as well as an awareness of safe and therapeutic dosage, and available resources/references. 5. The RN has the right and obligation to act as the patient’s advocate by refusing to administer or continue to administer, any medication not in the patient's best interest; this includes medications which might cause the patient's level of sedation to progress to deep sedation and/or loss of consciousness. The nurse should also feel s/he can suggest medications which may achieve the best result for the procedure. 6. In addition to the RN administering N2O/O2 a PALS certified RN or physician must be immediately available in the patient care area where the procedure is being performed. Equipment: 1. N2O/O2 sedation system specifically designed to deliver only oxygen at a minimum of 30% and Nitrous Oxide 2. Nitrous Oxide source (E cylinder) 3. Scavenger system- outer lumen of breathing circuit collects exhaled gas and is connected to wall suction for removal of expired gases. 4. Sedation mask and breathing circuit 5. Oxygen source – wall or E cylinder HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 4 of 8 APPROVED BY: 6. Pulse Oximeter 7. Emergency Resuscitative equipment 8. Suction Order: 1. May be ordered by LIP with documented competency; 2. Order states administer up to a maximum of 70% inhaled nitrous oxide with oxygen as the balancing gas. Pre- procedure: 1. Licensed Independent Practitioner Complete pre- sedation assessment and document using the Pre-Sedation Assessment in EMR. Review the patient’s medical history prior to the decision to order N2O/O2. The review will include at a minimum Any allergies or adverse drug reactions Current medications Diseases, disorders, or physical abnormalities Contraindications for use of Nitrous Oxide. Obtain parent or guardian consent (verbal) Enter order for N2O/O2 in EMR. 2. Registered nurse Urine HcG screen POCT per pregnancy screening guidelines The child is prepared for the procedure, preferably with the help of the Child Life Specialist, using age-appropriate methods. Procedure 1. Set up N2O/O2 delivery system and check fail safe mechanism. 2. Prepare patient for mask or nasal hood delivery process 3. Place pulse oximeter probe 4. Obtain vital signs to include B/P, HR, RR and Oxygen Saturation. 5. Using the Modified Aldrete 10 point scale assess baseline status 6. Place mask or nasal hood on patient to form a tight seal 7. Initially administer 50% Oxygen to assess for tight seal and patient response. 8. Titrate as needed Nitrous Oxide to a maximum of 70% to achieve adequate sedation. 9. RN administering N2O/O2 is at the patient’s side holding the mask, titrating the gas mix of Nitrous Oxide and Oxygen while monitoring the patient’s response and continuous pulse oximeter reading. 10. The RN responsible for administering the N2O/O2 may not leave the patient unattended or engage in other tasks that could distract from monitoring the patient. 11. Monitor and record pulse oximetry and level of consciousness every 5 minutes during procedure 12. A second RN or provider is responsible for performing the procedure. 13. Once the procedure is complete, Nitrous Oxide flow is discontinued and 100% Oxygen is delivered HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 5 of 8 APPROVED BY: via mask for 3-5 minutes until patient returns to a pre-sedation state. 14. Notify ordering provider if sedation was unsuccessful to plan for completing intended procedure. 15. In the event the patient experiences an unanticipated response, Nitrous Oxide is discontinued and 100% Oxygen is delivered. Additional support is provided based on presenting symptoms. Documentation: Documentation is completed in the electronic medical record using forms to include Pre-Sedation Assessment, Intra-procedural Monitoring and Post-Inhalation Assessment. Discharge: 1. Patient is monitored during the 3-5 minutes of 100% Oxygen delivery post end of N2O/O2 delivery. 2. Vital signs including B/P, HR, RR and Oxygen Saturation are measured and documented. 3. Patient is assessed using the Modified Aldrete 10 point scale to determine patient has returned to a baseline level of alertness and cognition. 4. Home care instructions provided related to procedure. May return to normal activities post N2O/O2 administration. Security: Nitrous Oxide tanks remain in a secured fashion with access limited to persons meeting qualifications to administer Nitrous Oxide. Performance Improvement 1. The utilization of N2O/O2 is continually reviewed for effectiveness and performance improvement opportunities. 2. All N2O/O2 administrations will be reviewed for performance improvement. Data is reported to MEC Sedation and Analgesic Committee and then to ACCM for review. REFERENCES: American Academy of Pediatrics. (1992). Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics, 89(6), 1110-1115. American Society of Anesthesiologists. (2002). Practice guidelines for sedation and analgesia by nonanesthesiologists. Anesthesia, 96(4),1004-1017. Arizona State Board of Nursing (2011). Advisory Opinion Nitrous Oxide Administration http:www.azbn.gov Babl, F., Oakley, E., Seaman, C., Barnett, P., & Sherwood, L. (2008). High-concentration nitrous oxide for procedural sedation in children: Adverse events and depth of sedation. Pediatrics, 121(3), e528-e532. DOI: 10.1542/peds.2007-1044 HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 6 of 8 APPROVED BY: Chapman, W., Arrowood, J.,& Beecher, H. (1943). The analgesic effects of low concentrations of nitrous oxide compared in man with morphine sulfate. Harvard Medical School Anesthesia Laboratory. Retrieved from http://www.jci.org/articles/view/101461/files/pdf Clark, M., & Brunick, A. (2008). Nitrous oxide and oxygen sedation. St Louis, MO: Mosby Elsevier. Farrell, M.K., Drake, G., Rucker, D., Finkelstein, M., & Zier, J. (2008). Creation of a registered nurse administered nitrous oxide sedation program for radiology and beyond. Pediatric Nursing, 34(1), 29-36 Fernandez-Guisasola, J., Gomez-Arnau, J., Cabrera, Y., & Garcia del Valle, S. (2010). Association between nitrous oxide and the incidence of postoperative nausea and vomiting in adults: a systematic review and meta-analysis Anaesthesia, 65, 379-387.DOI:10.1111/j. 1365-2044.2010.06249.x Orhan, M., Bilgin, F., Kilickaya, O., Atim, A., & Kurt, E. (2011). Nitrous oxide anesthesia in children for MRI: a comparison with isoflurane and halothane. Turk J Med Sci 41(3), 387-396. DOI: 10.3906/sag- 1003-660 Reyburn-Orne, T. (2013). Policy and Procedure for Nitrous Oxide Administration. Banner Children’s Hospital, Arizona Schechter, N. (2008). From the ouchless place to comfort central: The evolution of a concept. Pediatrics 122(3), S154-S160. DOI: 10.1542/peds.2008-1055h Seigh, R., Theophilos,T., & Babl, F. (2012). Intranasal Fentanyl and high- concentration inhaled nitrous oxide for procedural sedation: A prospective observational pilot study of adverse events and depth of sedation. Acad Emerg Med, 19(1), 31-36. Retrieved from http://www.pedsedation.org/sections/newsletters/2012 Yuxiang,L.,et al. (2012). Analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain: study protocol for a randomized controlled trial. Trials 3(67). DOI:10.1186/1745-6215-13-67 Zier, J., Drake, G., McCormick, P., Clinch, K., & Cornfield, D. (2007). Urinary catheterization in children. Anesthesia and Analgesia 104(4), 876-879. Reviewed By: Randall Wetzel MB, BS, FCCM, FAAP Mary Dee Hacker MBA, RN,NEA-BC, FAAN Nancy Blake MN, PhD, RN, NEA-BC, CCRN, FAAN Marilyn Mills BSN, RN, CRN, BC Samuel Yanofsky MD Marvin Nelson MD, MBA Sedation Committee HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: PREVIOUS NAME/NUMBER: CHAPTER: Appendix 1 PAGE NUMBER: Page 7 of 8 APPROVED BY: Initial and On-going Training and validation of Clinical Knowledge and Skills Required Licensed Independent Practitioner - Initial Maintain competency in moderate sedation Read the Handbook of Nitrous Oxide and Oxygen Sedation by Clark and Brunick 4rd ed. All chapters except 1.2.10.&19) Attend CHLA Didactic Education on the use of Nitrous Oxide/Oxygen Complete with 100% score the post-test validation Registered Nurse – Initial Maintain competency in moderate sedation Current PALS and BLS Attend CHLA Didactic Education on the use of Nitrous Oxide/Oxygen Complete with 100% score the post-test validation Demonstrate three successful Nitrous Oxide/Oxygen Mask administrations with a RN Proctor Didactic Education RN Delivered Nitrous Oxide/Oxygen for Minimal Sedation – 8 hrs Education provided by Radiology Nurse Manager, Radiology Nurse, Child Life Specialist, CHLA Respiratory Therapist, and Education Respiratory Therapist from Porter Praxair Corporation. Nitrous Oxide Overview Policy, procedure, and goals Ethical and legal considerations, Abuse Pharmacology – Mechanism of Nitrous Oxide Use and Contraindications Patient Selection Pain and Anxiety management Special considerations Consent Oral intake guidelines Symptoms of over-sedation Emergencies Anatomy and Physiology of Respiration and Airway Product Use Nitrous Oxide – Wall or Cylinders and Use Mask Administration Titration process Infection prevention Security Post Test/Evaluation HOSPITAL POLICY AND PROCEDURE MANUAL SUBJECT: Nurse Administered Nitrous Oxide/Oxygen for Procedural Minimal Sedation in Imaging Services CHLA ORIGINAL DATE: REVISED DATE: 12/4/14 REVIEWED DATE: CHAPTER: PREVIOUS NAME/NUMBER: PAGE NUMBER: Page 8 of 8 APPROVED BY: Prior to the RN independently administering N2O/O2 the nurse will successfully demonstrate proficiency in all aspects of this process using a manikin twice and then with proctor and patient for three procedures Proctoring is done by a nurse already deemed competent in this procedure. Annual demonstration of competency includes demonstration of procedure and 100% score on written test.