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University of Colorado Hospital Policy and Procedure Patient Controlled Analgesia (PCA): Adult and Pediatric Related Policy

and Procedures:
Central Venous Lines Peripheral Venous Lines Medication Management Pain Management: Adult and Pediatric Pyxis Medication System Controlled Medication Management Epidural and Intrathecal Infusion Analgesia Equipment Failure and Safety Hazard Reporting

Approved by:

Professional Practice Policy and Procedure Committee Effective: 6/99 Revised: 1/11 Revised: 3/14

Commented [AD1]: Inserted new date for policy revision

Description: This policy and procedure describes the process for patients to receive safe and
effective administration of parenteral opioid analgesics with a via the Alaris patient controlled analgesia (PCA) infusion device syringe module. The goals are: 1. To provide procedures for initiating, checking, and verifying PCA orders. 2. To provide procedures for PCA opioid use, dosage, and safe practice. 3. To standardize monitoring parameters. 4. To standardize documentation.
Commented [AD2]: Change per Alaris Team

Accountability:
1. A physician or allied health provider must order PCA infusions. Initial orders must be written on a pre-printed order form that includesusing an EPIC order set, which includes standard concentrations, dose settings and monitoring parameters. Subsequent PCA orders may be written on a standard physician order form. 2. Opioids or sedatives ordered in addition to a PCA should be authorized by the physician service that wrote the PCA orders before they are administered. This is required to prevent excessive sedation from other systemic controlled substances or sedatives. 3. New PCA orders will be written when a patient is transferred to another nursing unit (e.g., transfer in/out of ICU). PCA orders will be rewritten or renewed every 14 days. 4. All health care professionals (physicians, nurses, pharmacists) are accountable for verifying and checking PCA orders for accuracy. Physicians and nurses are accountable for checking the intravenous (IV) site for patency prior to starting an infusion and may initiate PCA pumps only if appropriately instructed. PACU nurses are accountable for initiating PCA infusions for postoperative patients prior to sending the patient to another nursing unit. 5. Pharmacists are accountable for supplying opioids for PCA in pre-mixed syringes/bags. Any drug wastage from the PCA pump must be witnessed and appropriately independently documented by two nurses, physicians and/or pharmacists as per the UCH Controlled Medication Management policy.
Commented [AD3]: Remove references to paper order forms

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Patient Controlled Analgesia (PCA): Adult and Pediatric

Definitions:
Bolus or Loading Dose: One time dose of medication that may be given at the start of a PCA infusion, or that may be given as an additional dose to supplement PCA therapy. Basal or Continuous Rate: The amount of medication automatically infused per hour. Incremental Demand or PCA Dose: The amount of medication infused when the patient presses the control button. Lockout or Delay Time: Period of time that must pass between the completion of one PCA dose and the initiation of the next. Patient Controlled Analgesia (PCA): Delivery of opioids via an electronic pump which enables the patient to self-administer small doses (usually IV) at frequent intervals, maintaining blood levels of opioids within an effective range. PCA by Proxy: Unauthorized administration of a PCA dose by anyone other than the patient, i.e., family members, caregivers, clinicians. This form of PCA therapy is not allowed at UCH.

Commented [AD4]: Change per Alaris Team

Table of Contents:
1. 2. 3. 4. 5. 6. 7. Verification of Orders PCA Opioid Use, Dosage, and Safe Practice Initiation of PCA Therapy Monitoring Documentation Education References

Policies and Procedures:


1. Verification of Orders All health care professionals who are administering PCA must verify and check PCA orders for accuracy and ensure that the patient is not allergic to the prescribed drug. The physicians order should contain the following: A. Name and strength concentration of drug (mg/ml or mcg/ml) B. Bolus or loading dose (mg or mcg) C. Basal or continuous rate (mg/hr or mcg/hr) D. Incremental Demand or PCA dose (mg or mcg) E. Lockout or delay time (minutes) F. Monitoring instructions (respiratory rate, sedation, pain intensity, etc.) 2. PCA Opioid Use, Dosage, and Safe Practice A. Suitable candidates for PCA include patients with pain who are mentally alert and able to comprehend and comply with instructions and procedures regarding its use. Patients who may not be suitable candidates include: infants and young children, patients with altered mental status (confusion, agitation, restlessness), patients with decreased level of consciousness, patients who are not psychologically stable, and patients without intellectual capacity to understand and operate the PCA. B. Demand dose (PCA) only is the safest mode for opioid nave patients and is normally used initially in the majority of patients with post-surgical or acute pain.

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Patient Controlled Analgesia (PCA): Adult and Pediatric


C. A basal infusion dose is normally only used in the opioid-tolerant patient, as needed. Opioid-tolerant is defined as those patients who have been receiving opioids regularly for approximately 7 days or more. A basal dose should not be increased more frequently than every 10-12 hours to allow steady state to be reached and the full effects of the dose increase to felt/observed. D. To reduce the risk of opioid-induced respiratory depression, monitoring of oxygenation by continuous pulse oximetry may be required by providers order. Risk factors for opioid-induced respiratory depression have been recognized in the literature and are noted in the box below. These risk factors should be considered when determining who might benefit from the use of mechanical monitoring via continuous pulse oximetry. Having a risk factor does not automatically require continuous pulse oximetry; the severity of the factor(s) and the patients condition should guide the decision to use continuous pulse oximetry. It should be noted that continuous pulse oximetry may be automatically required by specific nursing unit protocols. Risk Factors for Opioid-Induced Respiratory Depression 1. 2. 3. 4. 5. 6. 7. Use of a basal infusion dose in the non opioid-tolerant patient. Obstructive Sleep Apnea (OSA), or suspected of having OSA. Pulmonary disease or dysfunction (e.g., COPD). Obesity, BMI 35 kg/m2 Greater than 64 years old. Receiving other opioid or sedative drugs in addition to PCA. Impaired renal or hepatic function. Continuous Pulse Oximetry The severity of these factor(s) and the patients condition should guide the decision to use continuous pulse oximetry

E. PCA by Proxy is not allowed. Unauthorized administration of a PCA dose by anyone other than the patient, i.e., family members, caregivers, clinicians, can lead to over sedation, respiratory depression, and even death. If a patient is unable to self-administer their PCA dose, notify the physician service managing the PCA. Consideration should be given to discontinuing PCA therapy and utilizing alternate therapy such as IV push. Under no circumstances should anyone else push the PCA button for the patient. If the patient asks a health care provider to push their PCA button for them (e.g., patient cannot reach button), the provider should provide the button to the patient to administer their own dose. F. Initial PCA dosages for acute/postoperative pain in opioid nave adults: Opioid (Concentration) Morphine (1 mg/ml) Hydromorphone (0.2 mg/ml) Fentanyl (10 mcg/ml) Initial Loading 2 mg 0.4 mg 25 mcg Initial Basal Not Recommended Initial Incremental 1-2 mg 0.2-0.4 mg 10-25 mcg Initial Lockout 8 min. 8 min. 8 min.
Commented [AD8]: This table removed per Alaris Team Recommendations to avoid confusion with next table.

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Patient Controlled Analgesia (PCA): Adult and Pediatric


G.F. Usual range of PCA dosages for acute/postoperative pain in opioid nave adults: Usual Loading Range 10.5-4 mg 0.4-0.80.2-1 mg 2520-50 mcg Usual Basal Range 0-1 mg/hr 0-0.2 mg/hr 0-25 mcg/hr Usual Incremental Range 0.5-3 mg 0.1-0.50.6 mg 10-50 mcg Usual Lockout 8-10 min. 8-10 min. 6-10 min.
Commented [AD9]: Updated opioid concentrations Commented [AD10]: Updated to reflect current EPIC recommendations Formatted: Centered

Opioid (Concentration) Morphine (15 mg/ml) Hydromorphone (0.21 mg/ml) Fentanyl (150 mcg/ml)

Note: No limitation in dosing is implied by the above table. H.G. Basal rate is not routinely recommended in opioid nave patients. However, if a basal rate is ordered for an opioid nave patient, Tthe ratio of continuous (basal) dose to incremental (PCA) dose should remain approximately 1:2. I.H. Optimal opioid analgesic dose varies widely even among opioid-nave patients: adjust dosing based on patient response. J.I. For pediatric patients, the decision to use PCA will be based on their individual needs and abilities. Pediatric dosage will be by weight until 12 years of age/or 50 kg. The physician service managing the PCA must obtain consent from parent/legal guardian for pediatric patients under eighteen (18) years. Any special assessment, monitoring, or dose titration parameters should be established by the physician service managing the PCA when the infusion is ordered. K. Usual range of PCA dosages for acute/postoperative pain in pediatric patients: Opioid (Concentration) Morphine (1 mg/ml) Hydromorphone (0.2 mg/ml) Fentanyl (10 mcg/ml) Usual Loading Range 30 mcg/kg 5 mcg/kg 1 mcg/kg Usual Basal Range 0-30 mcg/kg/hr 0-5 mcg/kg/hr 0-1 mcg/kg/hr Usual Incremental Range 10-30 mcg/kg 3-5 mcg/kg 0.2-1 mcg/kg Usual Lockout 8-10 min. 8-10 min. 6-10 min.

Commented [AD11]: Change per Alaris Team

Commented [AD12]: Removed per Alaris Team; there is currently no pediatric entry built into the PCA pump or EPICs order sets.

Note: No limitation in dosing is implied by the above tables. J. PCA dosage ranges in the opioid-tolerant patient can be much higher than those listed in the above tables. The Acute Pain Service (APS) 303-266-6493 may be consulted to determine appropriate PCA dosages in this population. L.K. In addition to opioid nave and opioid tolerant, UCH has a third category of dosing parameters for the Palliative Care patient. The doses used in the Palliative Care/Oncology IV PCA order set are generally much larger than those for opioid nave and tolerant patients, and may require the use of special high concentration syringes/premixed bags of medication. Using this order set results in an automatic consult to the Palliative Care Team; this consult is required to use this order set. M.L. Nurses may adjust pump settings within ranges and give bolus doses as ordered. A second RN verification is NOT required for bolus doses.
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Commented [AD13]: Discuss existence of palliative care order set

Commented [AD14]: Make it very clear that two RNs not needed for PCA boluses

Patient Controlled Analgesia (PCA): Adult and Pediatric


N.M. Two RNs must independently verify drug, volume, concentration, and rate including all pump settings against the orders when: 1. Initiating the PCA infusion 2. Accepting patient from another floor 3. Changing shift (with off-going RN to oncoming RN) 4. Changing any settings or changing drug O.N. Meperidine (Demerol) is not available for PCA due to accumulation of an active metabolite, normeperidine, which can cause seizures and tremors. P.O. Morphine should be used with caution in patients with renal insufficiency due to its more potent active metabolite, morphine-6-glucuronide (M6G). M6G has decreased clearance and increased elimination half-life in these patients. Q.P. PCA opioids may be administered via a subcutaneous (SC) infusion in special circumstances when IV access is not possible. The pharmacy or the APS is available to assist in determining appropriate candidates and PCA dosages in this population. A Palliative Care Team consult is recommended when using the subcutaneous PCA order set (this is a physician to physician consult). This team will assist in determining appropriate candidates and PCA dosages. The following applies: 1. A single SC subcutaneous infusion site can usually accept 2-3 ml/hour. 2. Highly concentrated solutions (e.g., hydromorphone 1 or 10 mg/ml, or morphine 10505 mg/ml), or fentanyl (50mcg/ml) are used for SC subcutaneous infusion, and rates are in tenths of a millimeter (0.1 ml/hour). Fentanyl is not recommended for SC administration due to its lipophilic properties. 3. A 27-gauge butterfly subcutaneous needle is placed at a 45-degree angle according to manufacturers instructions in the outer quadrants of the abdomen or anatomical sites used for subcutaneous injections, bilateral subclavicular chest wall, or posterior scapular area; the site should allow a fat fold of at least 1 to be pinched between thumb and index finger. Avoid areas that are scarred, infected, irritated, edematous, bony, highly vascular, or near the waistline. Cachexia is not a contraindication for subcutaneous access, although available sites may be limited. The Ssite is prepped similar to in the same manner as placing an IV catheter and should be covered with a transparent dressing. Aspiration should NOT result in blood return. The site should be monitored according to the same parameters as an IV site for erythema, induration, leaking, bleeding, edema, infection, or tissue slough. The Ssite should be changed by the nurse minimum every 7 days, or more often if necessary (erythema, edema, leaking). 3.4.The administration set and pump should be clearly labeled subcutaneous infusion to prevent mistaking for an intravenous line. 4.5.Dosing is the same as for IV infusion; however, a longer initial drug onset time (approximately 20 minutes) must be allowed for due to slower absorption via the SC subcutaneous route. R.Q. Change PCA bag/syringe every 24 hours for UCH mixed solutions and every 72 hours for pre-mixed solutions. Change the tubing every 96 hours. S.R. The key to the PCA pump will be kept within a secured designated area, e.g., Pyxis machine on each unit. T.S. If a patient experiences an adverse event related to sedation or respiratory depression, examine the medication concentration and pump settings to assure they are
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Commented [AD15]: See ISMP list of approved abbreviations Commented [AD16]: Pall care consult required for subcutaneous PCAs

Commented [AD17]: No data in the literature stating this; where did it come from originally? Commented [AD18]: Updated info on subcutaneous placement based on literature; reference below

Patient Controlled Analgesia (PCA): Adult and Pediatric


correct. If no human errors are discovered: 1) Return the PCA pump with tag to Biomed for inspection. The pump must not be returned to use or to Central Supply; 2) The IV bag and tubing must be returned to the Pharmacy. Contact the Pharmacy Manager on call (303-266-0661) for instructions on disposition of the IV bag and tubing, based on time of day and day of the week. 3. Initiation of PCA Therapy A. Infusion medication and labeling 1. Manufacturer pre-mixed UCH pharmacy batched morphine syringes (30 ml, 15 mg/ml) and UH pharmacy prepared, hydromorphone bags syringes (530 ml, 0.21 mg/ml), and fentanyl bags syringes (10030 ml, 150 mcg/ml) are stocked in the Pyxis machine. These syringes are used for both the opioid nave and opioid tolerant PCA therapies. 2. Higher concentrations of all PCA opioids are only available on an as ordered basisusing the Palliative Care order set. The use of the Palliative Care order set requires a Palliative Care Consult order (this is a physician to physician consult order). This order set may be appropriate for patients who are extremely opioid tolerant, are nearing the end of life, or are undergoing an extreme pain crisis. The Palliative Care order set may also be appropriate if the patient is requiring greater than one full syringe of medication every four hours. (See the Alaris tip sheet, located on the Alaris Multidisciplinary website, for detailed instructions on setting up a highdose infusion.) 3. Verify compatibility of other drugs being administered before connecting the PCA line. 4. PCA tubing must be connected into a continuously running maintenance IVA continuously running maintenance IVF or carrier IVF must be connected into the PCA tubing. B. PCA Initiation: 1. Verify physician order 2. Ensure patient meets criteria for use of PCA 3. Gather equipment: a. PCA pump with lock box and keyAlaris Brain/Point of Care Unit (PCU) with one Large Volume Pump (LVP) module and one PCA syringe module a. Alaris PCA key b. Two replacement batteries c. PCA tubing with Y connector d. PCA extension tubing e.d. Syringe/bag with ordered medication 4. If the UCH Palliative Care/Oncology IV PCA order set is being used with a continuous rate infusing via the Alaris LVP, the following additional equipment is required: a. Alaris PCU with one LVP module (see Kaizen Bulletin: How to Administer Controlled Substance Infusions in Non-ICU Care Areas) b. Alaris controlled substance tubing c. CADD lockbox
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Commented [AD19]: Updated to reflect current UCH policy re: PCA syringes & concentrations

Commented [AD20]: Updated to reflect current use of higher PCA concentrations

Commented [AD21]: Per pharmacy Commented [AD22]: Inserted per Alaris Team

Commented [AD23]: Changed to reflect new tubing layout

Commented [AD24]: Changed to reflect new Alaris PCA

Commented [AD25]: Inserted to clarify needed items for large volume PCA dosing

Formatted

Patient Controlled Analgesia (PCA): Adult and Pediatric


d. CADD lockbox key 4.5.Wash hands. 5.6.Verify IV or subcutaneous site patency. 7. Follow the manufacturers instructions for setting up, loading, priming the tubing, and programming the PCA pump. 6.8.UCH Alaris pumps use Guardrails safety software to help ensure correct dosing of all IV medications administered to patients. These Guardrails include hard and soft maximum and minimum ranges for PCA basal rates, demand doses, boluses, loading doses, and lockout times. There are three different categories of patient under these Guardrails: opioid nave, opioid tolerant, and Palliative Care/Oncology. (Please refer to a UCH pharmacist or a smart pump technology team member for a list of current Guardrails standards.) When programming the pump, the correct category of patient must be selected in order for the appropriate Guardrails to apply. 7.9.Label tubing with date and time and sticker. 8.10. Two RNs must independently verify drug, volume, concentration, and rate including all pump settings against the orders. 9.11. After ensuring that PCA tubing is completely primed (including Y site connection) and attaching the maintenance IVF to the PCA tubing, Cconnect the PCA tubing to the patient, lock the PCA pump, and then start the pump. maintenance IV line, start the pump and lock the pump box. 10.12. Instruct the patient and family/significant other on the use of PCA. 4. Recommended Monitoring A. Recommended patient monitoring includes assessment and documentation of vital signs, sedation level, and pain intensity per PCA orders. Recommended monitoring parameters are: 1. Heart rate, blood pressure, temperature and pulse oximetry every 4 hours 2. Respiratory rate and sedation level every 1 hour x 12 hours, then every 2 hours x 12 hours, then every 4 hours until the PCA is discontinued. 3. If the PCA dose is increased (basal rate started or increased, demand dose increased, lockout frequency decreased, RN bolus given), temporarily increase the respiratory rate and sedation level monitoring to every 30 minutes x 2. 4. Assessment of the sleeping patient: a. Respiratory status should be observed without awakening the patient. Arousal will stimulate respiration and potentially mask pending problems. b. Observation should include the depth and regularity of respirations and listening for snoring. c. Shallow respirations, periods of apnea, or snoring may be a sign of over sedation or respiratory trouble and the patient should be awakened to further assess. d. If there is any question about whether the patient is sleeping normally or is sedated, they should be awakened to further assess. e. If respiratory rate and status are assessed as normal as noted above, it is not required to awaken the patient to assess sedation. Sedation scaleMoline-Roberts Pharmacologic Sedation Scale
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Commented [AD26]: Inserted to discuss Alaris Guardrails and appropriate use of patient categories of nave, tolerant, and pall care

Commented [AD27]: Inserted per Alaris Team Commented [AD28]: Changed to reflect new tubing layout

Commented [AD29]: Changed to reflect new sedation scale in use; reference inserted below Formatted: Centered Formatted Table

Patient Controlled Analgesia (PCA): Adult and Pediatric


5 = wide awake 3 = sleeping arousable 1 = not able to arouse 4 = drowsy 2 = difficult to arouse 1None to minimal sedation Awake, aware, alert; spontaneous sustained interaction 2Anxiolysis Restful, drowsy, dozing, lightly sleeping; soft voice, no tactile stimulus required or light touch, sustains interaction 3Moderate Sedation Sleeping, soft to normal voice, light touch, limited interaction 4Moderate Sedation Sleeping, normal to loud voice, light touch, follows simple commands 5Deep Sedation Sleeping, airway and ventilation may be impaired, loud voice, intense to noxious tactile stimulus, purposeful response or non-purposeful movement 6General Anesthesia Sleeping, airway and ventilation likely impaired, loud voice, noxious stimulus, no response/unarousable B. Increasing somnolence can be a key indicator of pending opioid induced respiratory depression. C. Assess the patients pain intensity at least every 4 hours and within 1 hour after bolus doses or rate/medication changes. D. Assess the patient for the following side effects and treat as needed: 1. Nausea and/or vomiting 2. Pruritus 3. Urinary retention 4. Constipation E. Immediately notify the ordering service for respiratory rate less than 10 per minute, sedation level of 2 or less 5 or more(difficult to arouse), or inadequate pain relief. F. If respiratory rate less than 8 per minute or sedation level of 16 (not able to arouse), stop infusion and administer naloxone 0.1 mg IV STAT, may repeat every 3-5 minutes x 3 doses to a total of 0.4 mg. G. The above monitoring parameters are minimum standards and should be increased as warranted by patient condition and orders. 5. Documentation A. The nurse is responsible to document the following on the appropriate patient information record: 1. Heart rate, blood pressure, temperature and pulse oximetry every 4 hours. 2. Respiratory rate and sedation level every 1 hour x 12 hours , then every 2 hours x 12 hours, then every 4 hours. 3. Two RNs must independently verify drug, volume, concentration, and rate including all pump settings against the orders when: a. Initiating the PCA infusion b. Accepting patient from another floor c. Changing shift (with off-going RN to oncoming RN)
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Patient Controlled Analgesia (PCA): Adult and Pediatric


d. Changing any settings or changing drug d.e. Changing an empty syringe to a full one Two RNs must witness and document wasting of controlled substances. The number of PCA button demands/deliveries and the total amount of medication (mg or mcg) used every 4 hours. After recording these amounts, clear the 4 hour shift total to reset the pump for the next 4 hour total. Pain intensity at least every 4 hours and within 1 hour after bolus doses or rate/medication changes, Sside effects/complications. Patient and family education on the Interdisciplinary Teaching Sheet.

4. 5.

6. 7.

6. Education A. Where appropriate, provide patient education sheet Patient Controlled Analgesia (PCA) (DOD# PED00105-0902 available in Spanish). Review with patient and family the principles of PCA therapy and proper use. Identify that no one but the patient is to administer a PCA dose. REFERENCES: 1. Parker, M. & Henderson, K. (2010). Alternative Infusion Access Devices. In M. Alexander, A. Corrigan, L. Gorski, J. Hankins, & R. Perucca (Eds.), Infusion Nursing: An EvidenceBased Approach (pp. 516-521). St. Louis, MO: Saunders Elsevier. (LOE ?) 1.2. American Pain Society (2008). Principles of Analgesic Use in the Treatment Of Acute Pain And Cancer Pain (6th Ed.). American Pain Society, Skokie, IL. (LOE VI) 2.3. Lehmann, K. (2005). Recent developments in Patient-Controlled Analgesia. Journal of Pain and Symptom Management. 29(5S) S72-S89. (LOE I) 3.4. Institute for Safe Medication Practice Newsletter (2009). Beware of basal opioid infusions with PCA therapy. March 12 issue. (LOE V) 4.5. Macintyre P. (2005). Intravenous patient-controlled analgesia: One size does not fit all. Anesthesiology Clinics of North America. 23, 109-123. (LOE VI) 6. McCaffery, M. & Pasero, C., (2010). Pain Assessment and Pharmacologic Management. St. Louis: Mosby. (LOE VI) 5.7. Moline, B. & Roberts, M. (2012). Validity and interrater reliability of the Moline-Roberts Pharmacologic Sedation Scale. Clinical Nurse Specialist. 26(3):140-148. (LOE ?) 6.8. Pasero, C. & McCaffery M., (2005). Authorized and unauthorized use of PCA pumps. American Journal of Nursing, 105(7), 30-32. (LOE VI) 7.9. Pasero, C. (2009). Assessment of sedation during opioid administration for pain management. Journal of Perianesthesia Nursing. 24(3):186-190. (LOE VI) 8.10. Patient controlled analgesia by proxy. Sentinel Event Alert. Dec 20, 2004. Available at http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_33.htm. Accessed 9/8/2005. (LOE V) c158411
Commented [AD31]: Reference for subcutaneous infusions. NEEDS LOE! Formatted: Font: Italic

Commented [AD32]: Reference for new sedation scale. NEEDS LOE!

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