Risk management and safety in the use of patient-controlled analgesia pumps: a scoping review
Gestão de risco e segurança no uso de bomba de analgesia controlada pelo paciente: revisão de escopo
Thamires Ribeiro da Silva; Erica Brandão de Moraes; Juliana Gomes Poubel; Carolina Rosa Figueiredo; Anderson de Souza Pereira
Abstract
BACKGROUND AND OBJECTIVES: Patient-controlled analgesia (PCA) is effective in controlling pain, but has numerous associated risks, such as: hypotension, respiratory depression, seizures and excessive sedation. The promotion of patient safety aims to reduce the risk of unnecessary health injuries and, therefore, it is important to analyze the failures and risk factors present throughout the process proactively. Therefore, the aim of this study was to map the available evidence on the risks of adverse events associated with the PCA technique and patient safety actions.
CONTENTS: This is a scoping review conducted according to the JBI methodology, whose research question was based on the PCC strategy. The source of information is open and the search occurred in three stages. The databases used were: Medline/Pubmed; LILACS; CINAHL/ EBSCOhost; CENTRAL; Portal Capes; SCOPUS; Web of Science; Google academic; Brazilian Digital Library of Theses and Dissertations; Portal NICE; and Portal ISMP. The search strategy was divided into 3 stages: the first occurred in Medline and Cinahl to identify articles and index terms on the topic; the second used all keywords in all included databases; the third consisted of tracking searches in the reference lists of the included studies. The search resulted in 1,164 studies, of which 83 were selected based on the inclusion criteria: addressing the risks associated with the ACP pump or safety measures, hospital context, without restriction as to the type of study, language, and year. The studies are distributed in categories: previous diseases, profile of indications, types of opioids, types of pump and infusion, adverse effects, incidents without harm, stages of risk, and safety measures.
CONCLUSION: This study made it possible to identify the risks of adverse events associated with the use of ACP in different stages and safety actions, demonstrating that when performed with appropriate patients, trained staff, safe devices, and correct prescription it provides a statistically significant improvement in pain relief, safely with advantages that conventional analgesia does not have.
Keywords
Resumo
JUSTIFICATIVA E OBJETIVOS: A analgesia controlada pelo paciente (ACP) é eficaz no controle da dor, porém apresenta inúmeros riscos associados, tais como: hipotensão arterial, depressão respiratória, convulsões e sedação excessiva. A promoção da segurança do paciente visa reduzir o risco de lesões desnecessárias à saúde e, para tanto, é importante analisar as falhas e fatores de risco presentes em todo o processo de forma proativa. Portanto, o objetivo deste estudo foi mapear as evidências disponíveis sobre os riscos de eventos adversos associados à técnica de ACP e a ações de segurança do paciente.
CONTEÚDO: Trata-se de uma revisão de escopo realizada segundo a metodologia Joanna Briggs Institute para Scoping Reviews, cuja questão de pesquisa se baseou na estratégia PCC (P: população; C: conceito; C: contexto). As bases de dados utilizadas foram: Medline/Pubmed, LILACS, CINAHL/EBSCOhost, CENTRAL, Portal Capes, SCOPUS, Web of Science, Google acadêmico, Biblioteca Digital Brasileira de Teses e Dissertações, Portal NICE, Portal ISMP. A estratégia de busca foi dividida em 3 etapas: a primeira ocorreu na Medline e Cinahl para identificar artigos e termos de índice sobre o tema; a segunda utilizou todas as palavras-chaves em todas as bases de dados incluídas; a terceira consistiu no rastreamento de pesquisas nas listas de referências dos estudos incluídos. A busca resultou em 1.164 estudos, dos quais 83 foram selecionados com base nos seguintes critérios de inclusão: abordagem dos riscos associados à bomba de ACP ou a medidas de segurança, contexto hospitalar, sem restrição quanto ao tipo de estudo, idioma e ano. Os achados sintetizados estão distribuídos em categorias: doenças prévias, perfil das indicações, tipos de opioides, tipos de bomba e de infusão, efeitos adversos, incidentes sem lesões, estágios de risco e medidas de segurança.
CONCLUSÃO: Este estudo possibilitou identificar os riscos de eventos adversos associados ao uso da ACP em diferentes estágios e ações de segurança, demonstrando que quando realizada com pacientes adequados, com equipe treinada, dispositivos seguros e prescrição correta, fornece uma melhora estatisticamente significativa no alívio da dor, de forma segura e com vantagens que a analgesia convencional não possui.
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Referências
1 Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;21(9):1976-82.
2 Resnik DB, Rehm M, Minard RB. The under-treatment of pain: scientific, clinical, cultural and philosophical factors. Med Health Care Philos. 2001;4(3):277-88.
3 Mather LE, Owen H. The scientific basis of patient-controlled analgesia. Anaesth Intens Care. 1988;16(4):427-47.
4 Langdale A. Analgésie contrôlée par le patient. Bénéfices, risques, modalités de surveillance. Ann Fr Anesth Réanim. 1998;17(6):58-98.
5 Clinical Excellence Comission. Clinical Focus Report Patient Controlled Analgesia. 2013 [acesso em 2022 out 24]. Disponível em:
6 Institute For Safe Medication Practices. ISMP Develops Guidelines for Standard Order Sets. 2010 [acesso em 2022 out 24]. Disponível em:
7 Reason J. Human error: models and management. Brit Med J. 2000;320(7237):768-70.
8 Reason J. Human error. Cambridge University Press. 2003.
9 Yarmohammadian MH, Abadi TN, Tofighi S, Esfahani SS. Performance improvement through proactive risk assessment: Using failure modes and effects analysis. J Educ Health Promot. 2014;3:28.
10 Aromataris E, Munn Z. JBI Manual for Evidence Synthesis. Joanna Briggs Institute. 2020 [acesso em 2022 out 24]. Disponível em:
11 Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.
12 Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, Moher D, Peters MDJ, Horsley T, Weeks L, Hempel S, Akl EA, Chang C, McGowan J, Stewart L, Hartling L, Aldcroft A, Wilson MG, Garritty C, Lewin S, Godfrey CM, Macdonald MT, Langlois EV, Weiser KS, Moriarty J, Clifford T, Tunçalp O, Straus SE. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018;169(7):467-73.
13 Lisi DM. Patient-controlled analgesia and the older patient. US Pharm. 2013;38(3):2-6.
14 Tsui SL, Irwin MG, Wong CM, Fung SK, Hui TW, Ng KF, Chan WS, O’Reagan AM. An audit of the safety of an acute pain service. Anaesthesia. 1997;52(11):1042-7.
15 Dening F. Patient-controlled analgesia. Br J Sch Nurs. 1993;2(5): 274-7.
16 Elannaz A, Chaumeron A, Viel E, Ripart J. Morphine overdose due to cumulative errors leading to ACP pump dysfunction. Ann Fr Anesth Reanim. 2004;23(11):1073-5.
17 Institute For Safe Medication Practices. Safety Issues with Patient-Controlled Analgesia Part I - How erros occur. KBN Connection. 2005;3(1):21-3.
18 Dev R, Fabbro ED, Bruuera E. Patient-controlled analgesia in patients with advanced cancer. Should patients be in control? J Pain Symptom Manage. 2011;42(2):296-300.
19 Cohen H. Avoid PCA errors with education. Don’t let family members administer medication. Hospital Home Health. 2004;21(5):56-7.
20 Musshoff F, Padosch S, Madea B. Death during patient-controlled analgesia: piritramide overdose and tissue distribution of the drug. Forensic Sci Int. 2005;154(2-3):247-51.
21 Syed S, Paul JE, Hueftlein M, Kampf M, McLean RF. Morphine overdose from error propagation on an acute pain service. Reg Anesth Pain. 2006;53(6):586-90.
22 Abrolat M, Eberhart LHJ, Kalmus G, Koch T, Nardi-Hiebl S. Patientenkontrollierte analgesie: methoden, handhabung und ausbaufähigkeit. Anästhesiol Intensivmed Notfallmed Schmerzther. 2018;53(4):270-80.
23 Ahmad I, Thompson A, Frawley M, Hu P, Heffernan A, Power C. Five-year experience of critical incidents associated with patient-controlled analgesia in an Irish University Hospital. Ir J Med Sci. 2010;179(3):393-7.
24 D’arcy Y. Eyeing capnography to improve PCA safety. Nursing. 2007;37(9):18-9.
25 D’arcy Y. Keep your patient safe during PCA. Nursing. 2008;38(1):51-5.
26 Lederer W, Benzer A, Doyle DJ. Programming errors from patient-controlled analgesia. Can J Anaesth. 2003;50(8):854-6.
27 Institute For Safe Medication Practices. Safety Issues with Patient-Controlled Analgesia Part II - Pratical Error-Reduction Strategies. KBN Connection. 2005;3(1):21-3.
28 Cohen MR, Smetzer J. Patient-controlled analgesia safety issues. J Pain Palliat Care Pharmacother. 2005;19(1):45-50.
29 Cohen MR. Safety issues with patient-controlled analgesia wake-up call: unlabeled containers lead to patient’s death. Hospital Pharmacy. 2005;40(2):117-26.
30 Lattavo K. Safe use of patient-controlled analgesia on a medical-surgical unit. Acad Med-Surg Nurses. 2010;19(2):11-4.
31 Notcutt WG, Morgan RJ. Introducing patient-controlled analgesia for postoperative pain control into a district general hospital. Anaesthesia. 1990;45(5):401-6.
32 Hicks RW, Becker SC, Krenzischeck D, Beya SC. Medication errors in the PACU: a secondary analysis of MEDMARX findings. J Perianesth Nurs. 2004;19(1):18-28.
33 Hicks RW, Hernandez J, Wanzer LJ. Perioperative pharmacology: patient-controlled analgesia. AORN J. 2012;95(2):255-65.
34 Ohashi K, Dykes P, Mcintosh K, Buckley E, Yoon C, Luppi C, Bane A, Bates DW. Evaluation of use of electronic patient controlled analgesia pumps to improve patient safety in an academic medical center. Stud Health Technol Inform. 2014;201:153-9.
35 Alberta RN. Beware of basal opioid infusions with PCA therapy. Alta RN. 2009;65(9):12-3.
36 Etches RC. Patient-Controlled analgesia. Surg Clin North Am. 1999;79(2):297-312.
37 Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1995;64(2):357-64.
38 Paul JE, Bertram B, Antoni K, Kampf M, Kitowski T, Morgan A, Cheng J, Thabane L. Impact of a comprehensive safety initiative on patient-controlled analgesia errors. Anesthesiology. 2010;113(6):1427-32.
39 Pasero CL. PCA: for patients only. Am J Nurs. 1996;96(9):22-3.
40 Sardin B, Lecour N, Terrier G, Grouille D. À propos des paramètres de sécurité des pompes d’analgésie contrôlée par le patient (PCA). Ann Fr Anesth Reanim. 2012;31(10):813-7.
41 Grissinger M. Fatal PCA adverse events continue to happen: better patient monitoring is essential to prevent harm. P T. 2016;41(12):736-7.
42 Institute For Safe Medication Practices. PCA by proxy - an overdose of care. Patient Saf Advis. 2005;2(2):23-4.
43 Institute For Safe Medication Practices. Worth Repeating… Recent PCA By Proxy Event Suggests Reassessment of Practices that May Have Fallen by the Wayside. 2016 [acesso em 2022 25 out]. Disponível em:
44 Vicente KJ, Bekhaled KK, Hillel G, Cassano A, Orser BA. Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability. Can J Anaesth. 2003;50(4):328-32.
45 Akridge J. New pumps outsmart user error. 2011 [acesso em 2022 25 out]. Disponível em:
46 Kluger MT, Owen H. Patient-controlled analgesia: can it be made safer? Anaesth Intensive Care. 1991;19(3):412-20.
47 Chumbley G, Mountford L. Patient-controlled analgesia infusion pumps for adults. Nurs Stand. 2010; 25(8):35-40.
48 American Nurse Association. Avoid the dangers of opioid therapy. 2009 [acesso em 2022 25 out]. Disponível em:
49 D’Arcy Y. Keep your patient safe during PCA. Nursing. 2008;38(1):5-50.
50 D’Arcy Y. Patient safety issues with patient-controlled analgesia. Topics in Advanced Pract Nurs J. 2007;7(1).
51 Stewart D. Pearls and pitfalls of patient-controlled analgesia. US Pharm. 2017;42(3):24-7.
52 Etches RC. Respiratory depression associated with patient-controlled analgesia: a review of eight cases. Can J Anaesth. 1994;41(2):125-32.
53 Reimer HD. Intravenous dead space and patient safety in patient-controlled analgesia. Can J Anaesth. 1995;42(7):658.
54 Cohen MR. Misprogramming patient-controlled analgesia concentration leads to dosing errors. Hospital Pharmacy. 2008;43(12):960-4.
55 Dunwoody C, Skledar S, Freeman S. Changes in patient-controlled analgesia following a meperidine overdose. Jt Comm J Qual Patient Saf. 2006;32(9):528-30.
56 Weber LM, Ghafoor VL, Phelps P. Implementation of standard order sets for patient-controlled analgesia. Am J Health Syst Pharm. 2008;65(12):1184-91.
57 Cheymol G. Effects of obesity on pharmacokinetics. Clin Pharmacokinet. 2000;39(3):215-31.
58 Bakir M, Atici SR, Yildirim HU, Tiftik EN, Unal S. Patient-controlled analgesia and morphine consumption in sickle cell anemia painful crises: a new protocol. Agri. 2020;32(3):115-9.
59 Vandercar DH, Martinez AP, Lisser EA. Sleep apnea syndromes: a potential contraindication for patient-controlled analgesia. Anesthesiology. 1991;74(3):623-4.
60 Tawfic QA, Bellingham G. Postoperative pain management in patients with chronic kidney disease. J Anaesthesiol Clin Pharmacol. 2015;31(1):6-13.
61 Wasylak TJ, Michael JM, Jeans ME. Reduction of postoperative morbidity following patient-controlled morphine. Can J Anaesth. 1990;37(7):726-31.
62 Fernandes MTP. Patient-Controlled Analgesia (PCA) in Acute Pain: Pharmacological and Clinical Aspects. Pain Relief. 2017 [acesso em 2022 out 25]. Disponível em:
63 Prommer E. Patient Controlled Analgesia in Palliative Care. Palliative care network of Wisconsin. 2009 [acesso em 2022 out 25]. Disponível em:
64 Citron ML, Early AJ, Boyer M, Krasnow SH, Hood M, Cohen MH. Patient-controlled analgesia for severe cancer pain. Arch Intern Med. 1986;146(4):734-6.
65 Momeni M, Cruvitti M, Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37.
66 Mcpherson ML. Demystifying Opioid Conversion Calculations: A Guide for Effective Dosing. 2a ed. 2010.
67 Duarte LTD, Fernandes MCBC, Costa VV, Saraiva RA. The incidence of postoperative respiratory depression in patients undergoing intravenous or peridural analgesia with opioids. Rev Bras Anestesiol. 2009;59(4):409-20.
68 Grass JA. Patient-controlled analgesia. Anesth Analg. 2005;101(5):44-61.
69 Hagmeyer KO, Mauro LS, Mauro VF. Meperidine-related seizures associated with patient-controlled analgesia pumps. Ann Pharmacother. 1993;27(1):29-32.
70 Craft J. Patient-controlled analgesia: Is it worth the painful prescribing process? Proc Bayl Univ Med Cent. 2010;23(4):434-8.
71 Giuliano KK, Ruppel H. Are smart pumps smart enough? Nursing. 2017;47(3):64-6.
72 San Diego Patient Safety Council. Tool Kit Patient Controlled Analgesia (PCA) Guidelines of Care For the Opioid Naïve Patient. 2009.
73 Institute For Safe Medication Practices. High-Alert Medications in Acute Care Settings. 2018 [acesso em 2022 out 25]. Disponível em:
74 Conselho Regional de Enfermagem de São Paulo. Uso seguro de medicamentos: guia para preparo, administração e monitoramento. 2017 [acesso em 2022 out 25]. Disponível em:
75 Srinivas K. Process of Risk Management. IntechOpen. 2019.
76 Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21(10):541-8.
77 Chisakuta AM. Nurse-call button on a patient-controlled analgesia pump. Anaesthesia. 1993;48(1):90.
78 Hicks RW. Death by PCA. AORN. 2013;99(66):782-832.
79 Berry K. Root cause analysis in response to a “Near Miss”. J Healthc Qual. 2000;22(2):16-8.
80 Chumbley GM, Ward L, Hall GM, Salmon P. Pre-operative information and patient-controlled analgesia: much ado about nothing. Anaesthesia. 2004;59(4):354-8.
81 Chumbley GM, Hall GM, Salmon P. Patient-controlled analgesia: what information does the patient want? J Adv Nurs. 2002;39(5):459-71.
82 D’Arcy Y. PCA by proxy: taking the patient out of patient-controlled analgesia: this controversial practice can be done safely in carefully controlled circumstances. Dimens Crit Care Nurs. 2013;32(4):200-3.
83 Farbstein K, Clough J. Improving medication safety across a multihospital system. Jt Comm J Qual Improv. 2001;27(3):123-37.
84 Ferguson R, Williams ML, Beard B. Combining quality improvement and staff development efforts to decrease patient-controlled analgesia pump errors. J Nurses Staff Dev. 2010;26(5):E1-4.
85 Golembiewski J, Dasta J, Palmer PP. Evolution of patient-controlled analgesia: from intravenous to sublingual treatment. Hosp Farm. 2016;51(3):214-29.
86 Hankin CS, Schein J, Clark JA, Panchal S. Adverse events involving intravenous patient-controlled analgesia. Am J Health Syst Pharm. 2007;64(14):1492-9.
87 Heath ML. Safety of patient controlled analgesia. Anaesthesia. 1995;50(6):573.
88 Hicks RW, Sikirica V, Nelson W, Schein JR, Cousins DD. Erros de medicação envolvendo analgesia controlada pelo paciente. Am J Health Syst Pharm. 2008;65(5):429-40.
89 Tran M, Ciarkowski S, Wagner D, Stevenson JG. A case study on the safety impact of implementing smart patient-controlled analgesic pumps at a tertiary care academic medical center. Jt Comm J Qual Patient Saf. 2012;38(3):112-9.
90 Ladak SS, Chan VW, Easty T, Chagpar A. Right medication, right dose, right patient, right time, and right route: how do we select the right patient-controlled analgesia (PCA) device? Pain Manag Nurs. 2007;8(4):140-5.
91 Lee Y, Kim K, Kim M. CE: original research: errors in postoperative administration of intravenous patient-controlled analgesia: a retrospective study. Am J Nurs. 2019;119(4):22-7.
92 Moss J. Reducing errors during patient-controlled analgesia therapy through failure mode and effects analysis. Jt Comm J Qual Patient Saf. 2010;36(8):359-64.
93 Pasero C, McCaffery M. Authorized and unauthorized use of PCA pumps: clarifying the use of patient-controlled analgesia, in light of recent alerts. Am J Nurs. 2005;105(7):30-1, 33.
94 Paul JE, Buckley N, McLean RF, Antoni K, Musson D, Kampf M, Buckley D, Marcoux M, Frketich R, Thabane L, Cheng J. Hamilton acute pain service safety study: using root cause analysis to reduce the incidence of adverse events. Anesthesiology. 2014;120(1):97-109.
95 Peters L, Mcguire T, Ridling D. Proactive patient safety and opioids: failure mode effect analysis (FMEA) applied to patient controlled analgesia (PCA). J Pain. 2014;15(4):S94.
96 Pon D, Huang J. Identification of inappropriate patient-controlled analgesia (PCA) prescribing patterns to improve patient safety. J Pain. 2015;16(Suppl): S88.
97 Prewitt J, Schneider S, Horvath M, Hammond J, Jackson J, Ginsberg B. PCA safety data review after clinical decision support and smart pump technology implementation. J Patient Saf. 2013;9(2):103-9.
98 Russell J, Middleton C, Hale J. PCA test protocol delivers potentially fatal morphine overdose . Anaesthesia. 2012;67(7):802.
99 Schein JR, Hicks RW, Nelson WW, Sikirica V, Doyle DJ. Patient-controlled analgesia-related medication errors in the postoperative period: causes and prevention. Drug Saf. 2009;32(7):549-59.
100 Schug SA, Torrie JJ. Safety assessment of postoperative pain management by an acute pain service. Pain. 1993;55(3):387-91.
101 Shola UR, Neela Narayanan V. A review on patient-controlled analgesia infusion system. Asian J Pharm Clin Res. 2017;10(13):117-21.
102 Sidebotham D, Dijkhuizen MR, Schug SA. The safety and utilization of patient-controlled analgesia. J Pain Symptom Manage. 1997;14(4):202-9.
103 Sousa AM, de Santana Neto J, Guimaraes GM, Cascudo GM, Neto JO, Ashmawi HA. Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study. Supp Care Cancer. 2014;22(3):795-801.
104 Reg S, David L. Respiratory care departments take a lead role in postoperative monitoring. J Respir Care Pract. 2013;25(7):8-12.
105 Stone M, Wheatley B. Patient-controlled analgesia. Br J Anaesth. 2002;2(3): 79-82.
106 Surprise JK, Simpson MH. PCA: is that patientor provider-controlled analgesia? J Radiol Nurs. 2014;33(1):18-22.
107 Tan TY, Schug SA. Safety aspects of postoperative pain management. Rev Analg. 2006;9(1):45-53.
108 Taylor SA. Safety and satisfaction provided by patient-controlled analgesia. Dimens Crit Care Nurs. 2010;29(4):163-6.
109 Teng Y, Hu JS, Tsai SK, Liew C, Lui P. Efficacy and adverse effects of patient-controlled peridural or intravenous analgesia after major surgery. Chang Gung Med J. 2004;27(12):877-86.
110 Thomas VJ, Rose FD. Patient-controlled analgesia: a new method for old. J Adv Nurs. 1993;18(11):1719-26.
111 Viscusi ER. Emerging treatment modalities: balancing efficacy and safety. Am J Health Syst Pharm. 2007;64(4):S6-11.
112 Viscusi ER. Patient-controlled drug delivery for acute postoperative pain management: a review of current and emerging technologies. Reg Anesth Pain Med. 2008;33(2):146-58.
113 Weininger S, Jaffe MB, Rausch T, Goldman JM. Capturing essential information to achieve safe interoperability. Anesth Analg. 2017;124(1):83-94.
114 Weir VL. Preventing adverse drug events. Nurs Manag. 2005;36(9):24-30.
115 White E. A problem with the Graseby 3300 PCA pump. Anaesthesia. 1993;48(11):1013-4.
116 Williams J. Saving lives, saving families: continuous monitoring for patients on opioids. Biomed Instrum Technol. 2015;49(1):40-4.
117 Wong M, Mabuyi A, Gonzalez B. First National Survey of Patient-Controlled Analgesia Practices. In: Society of Anesthesia and Sleep Medicine (SASM) 3rd Annual Conference, 2013.
Submetido em:
25/10/2022
Aceito em:
20/07/2022