We commend Dr. Daniel Orr II and William Curtis’ November JADA article, "Obtaining Written Informed Consent for the Administration of Local Anesthetic in Dentistry" (
JADA 2005;136:1568–71
), for addressing the challenging issue of informed consent as it relates to local anesthesia.
We agree that the informing duty involved in "informed consent" can be stated as "the process by which a patient is apprised (informed) of the nature and risks of a proposed treatment ... ." We also assert that informed consent includes the relative "pros" and "cons" of potential treatments. This would include information about the relative risks associated with the products typically used to achieve anesthesia.
Empirical evidence1–4 indicates that some local anesthetics have a significantly higher rate of paresthesia associated with their use than others, and we believe it is important to inform the patient of the relative risks associated with various anesthetic products to be used by the doctor.
When using a higher-risk agent, the added risk should be described, along with the benefit of its use. The product insert for Septocaine 5 indicates that the Septodont-sponsored U.S. Food and Drug Administration study on Septocaine reported 11 cases of paresthesia with 882 patient treatments. This equates to one paresthesia in every 80 patient treatments. The insert also lists other adverse events experienced by less than 1 percent of the patients in the study. The list includes other nervous system problems, such as facial paralysis, hyperesthesia, neuropathy and paresthesia.
The reader is referred to two examples from the literature.1,2 One of the articles, "A 21 Year Retrospective Study of Reports of Paresthesia Following Local Anesthetic Administration," includes a graph and tables on paresthesias associated with the local anesthetics available in Canada. The article reported that in 1993 there were 10 paresthesias with articaine, four with prilocaine and zero paresthesias with any other local anesthetic. Where the local anesthetic agent was known, the authors indicated articaine was associated with 50 paresthesias, bupivacaine with zero, lidocaine with five, mepivacaine with four and prilocaine with 43 paresthesias. The authors concluded that there was a significantly higher paresthesia rate with articaine and prilocaine, compared with the other local anesthetic agents.
Two other studies3,4 in Ontario, Canada, subsequently substantiated those findings. The use of product inserts, practitioner experience, the references we have cited here and other literature on the subject would be useful in providing patients with the information necessary for an informed decision related to the use of local anesthetics. Information about the provider’s experiences with each of the local anesthetics should not overshadow a frank discussion of the information contained in the product insert. While practitioners and patients both may be reluctant to have such discussions, good ethics and prudence call for them, in our view.
Although paresthesias associated with local anesthesia were once a rare phenomenon, such has not been the case since the introduction of 4 percent local anesthetics, such as articaine and prilocaine.2
The ethics of good practice is not a static thing. As technology changes, practice must change with it. Patients deserve the full story, even if it includes uncomfortable information, and doctors themselves will benefit from an open discussion in the long run, as thorough informed consent tends to buffer them from the negative impact of litigation.
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