[About safety parameters for patient-controlled analgesia (PCA) devices]. 2012

B Sardin, and N Lecour, and G Terrier, and D Grouille
Service d'accompagnement et de soins palliatifs, pôle clinique médicale, CHU Dupuytren 87042 Limoges cedex, France. Electronic address: bertrand.sardin@chu-limoges.fr

During the course of preparation of an opioid prescription, the nurse in charge became aware that the patient-controlled analgesia (PCA) syringe driver did not permit programming for the delivery as required: a maximum bolus number (Bmax) was indicated but only a maximum cumulative dose (Dcmax) could be programmed. The prescription dose criteria were consistent with the guidelines of the French societies of palliative care, anesthesiology, and reanimation (Société française d'accompagnement et de soins palliatifs [Sfap] and Société française d'anesthésie réanimation [Sfar]). A Dcmax dose simulation was programmed and used in order to test this problem. This highlighted the following four defects: bolus delivery is not controlled, leading to potential overdose. When Dcmax is reached, the continuous flow stops, triggering an end dose failure and a new programming step is needed to restart infusion, increasing the risk of programming errors. Human intervention is required to stop the alarm, identify and solve the problem. Finally, Dcmax leads to random dose delivery in place of the predictability of dose delivery expected for opioid administration. On the other hand, Bmax is a limited dose, administered only as a bolus and regulated by the lockout interval. When the Bmax dose is reached, no alarm is triggered, the basal flow continues, but no additional doses can be delivered. Bmax and Dcmax systems are not interchangeable. No comparative study between Bmax and Dcmax could be found, and Sfap and Sfar guidelines are not precise and did not take into consideration the safety aspects of dose delivery however some facts tend to prefer that Bmax. Most of the syringe driver devices are configured for the Dcmax, but not all of them, and the physician is often forced to use the parameter of the available device restricting the choice between Bmax and Dcmax. This is not justified, whether by scientific evidence, industrial, manufacturing or commercial standards. It becomes only a technical option that does not promote standardization of dose delivery and compromises the main safety feature of PCA.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010149 Pain, Postoperative Pain during the period after surgery. Acute Post-operative Pain,Acute Postoperative Pain,Chronic Post-operative Pain,Chronic Post-surgical Pain,Chronic Postoperative Pain,Chronic Postsurgical Pain,Pain, Post-operative,Persistent Postsurgical Pain,Post-operative Pain,Post-operative Pain, Acute,Post-operative Pain, Chronic,Post-surgical Pain,Postoperative Pain, Acute,Postoperative Pain, Chronic,Postsurgical Pain,Postoperative Pain,Acute Post operative Pain,Chronic Post operative Pain,Chronic Post surgical Pain,Chronic Postsurgical Pains,Pain, Acute Post-operative,Pain, Acute Postoperative,Pain, Chronic Post-operative,Pain, Chronic Post-surgical,Pain, Chronic Postoperative,Pain, Chronic Postsurgical,Pain, Persistent Postsurgical,Pain, Post operative,Pain, Post-surgical,Pain, Postsurgical,Post operative Pain,Post operative Pain, Acute,Post operative Pain, Chronic,Post surgical Pain,Post-operative Pains,Post-surgical Pain, Chronic,Postsurgical Pain, Chronic,Postsurgical Pain, Persistent
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000230 Adenocarcinoma A malignant epithelial tumor with a glandular organization. Adenocarcinoma, Basal Cell,Adenocarcinoma, Granular Cell,Adenocarcinoma, Oxyphilic,Adenocarcinoma, Tubular,Adenoma, Malignant,Carcinoma, Cribriform,Carcinoma, Granular Cell,Carcinoma, Tubular,Adenocarcinomas,Adenocarcinomas, Basal Cell,Adenocarcinomas, Granular Cell,Adenocarcinomas, Oxyphilic,Adenocarcinomas, Tubular,Adenomas, Malignant,Basal Cell Adenocarcinoma,Basal Cell Adenocarcinomas,Carcinomas, Cribriform,Carcinomas, Granular Cell,Carcinomas, Tubular,Cribriform Carcinoma,Cribriform Carcinomas,Granular Cell Adenocarcinoma,Granular Cell Adenocarcinomas,Granular Cell Carcinoma,Granular Cell Carcinomas,Malignant Adenoma,Malignant Adenomas,Oxyphilic Adenocarcinoma,Oxyphilic Adenocarcinomas,Tubular Adenocarcinoma,Tubular Adenocarcinomas,Tubular Carcinoma,Tubular Carcinomas
D000701 Analgesics, Opioid Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. Opioid,Opioid Analgesic,Opioid Analgesics,Opioids,Full Opioid Agonists,Opioid Full Agonists,Opioid Mixed Agonist-Antagonists,Opioid Partial Agonists,Partial Opioid Agonists,Agonist-Antagonists, Opioid Mixed,Agonists, Full Opioid,Agonists, Opioid Full,Agonists, Opioid Partial,Agonists, Partial Opioid,Analgesic, Opioid,Full Agonists, Opioid,Mixed Agonist-Antagonists, Opioid,Opioid Agonists, Full,Opioid Agonists, Partial,Opioid Mixed Agonist Antagonists,Partial Agonists, Opioid
D013125 Spinal Neoplasms New abnormal growth of tissue in the SPINE. Neoplasm, Spinal,Neoplasms, Spinal,Spinal Neoplasm
D013274 Stomach Neoplasms Tumors or cancer of the STOMACH. Cancer of Stomach,Gastric Cancer,Gastric Neoplasms,Stomach Cancer,Cancer of the Stomach,Gastric Cancer, Familial Diffuse,Neoplasms, Gastric,Neoplasms, Stomach,Cancer, Gastric,Cancer, Stomach,Cancers, Gastric,Cancers, Stomach,Gastric Cancers,Gastric Neoplasm,Neoplasm, Gastric,Neoplasm, Stomach,Stomach Cancers,Stomach Neoplasm
D013594 Syringes Instruments used for injecting or withdrawing fluids. (Stedman, 25th ed) Hypodermic Syringes,Syringe, Karman,Hypodermic Syringe,Karman Syringe,Syringe,Syringe, Hypodermic,Syringes, Hypodermic

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