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Commentary & Perspective | ||||||||
Commentary & Perspective on Miller et al. have addressed a clinical issue that is confronted on a daily basis by physicians throughout the world, and they have performed their study at a time when both methodology and the implications of treatment recommendations are under intense scrutiny by patients, colleagues, and others involved in the managed health-care system. The rigor of this study by Miller et al. is commendable and their conclusions have the potential to change medical practice. It is generally agreed that randomized, controlled trials provide the highest level of evidence in the differential assessment of methods of treatment. Bhandari et al. reported that only seventy-two of 2468 (2.9%) clinical studies published in The Journal of Bone and Joint Surgery between 1988 and 2000 were randomized trials1, and of these, only eight (11%) addressed an upper-extremity disorder. Miller and co-authors conducted a prospective, randomized trial with clear inclusion and exclusion criteria to test the hypothesis that intra-articular lidocaine, in comparison with intravenous sedation, was efficacious in facilitating the reduction of acute anterior glenohumeral dislocations. The method of randomization involved the use of medical record numbers. Of the patients who met the study criteria and agreed to participate, those with odd medical record numbers received a local intra-articular injection of lidocaine and those with even medical record numbers received intravenous sedation. This method of randomization is suboptimal because, ideally, the method of randomization should be concealed from the treating physician. The study group consisted of thirty patients and the modified Stimson method that was used to reduce their shoulders was successful in all cases, although five patients required scapular manipulation to achieve reduction. The figures in the manuscript illustrate the technique well. The methodology included a self-reported assessment of pain, with use of a visual analog pain scale, and a comparative cost analysis of the two treatments. The time required for the reduction was not significantly different between the treatment groups nor was the average pain score. However, the patients who received intravenous sedation were in the emergency room almost two and one half times longer than those whose shoulder were reduced with use of intra-articular lidocaine (p < 0.01), and there was a very substantial difference in cost between the two methods of analgesia. In the Discussion, the authors noted that intravenous sedation has been associated with respiratory side effects that may require hospital admission2. They reviewed previous studies comparing intra-articular lidocaine with intravenous sedation that had methodological deficiencies such as a lack of randomization and different methods of manual reduction that made comparison between the methods of pain control difficult2,3. They also noted that the only potentially devastating complication of their technique would be the development of an infection in the shoulder, a complication not observed in their study. In their series, Miller et al. observed that the degree of staff supervision required to monitor patients in the emergency room was decreased with the use of intra-articular lidocaine. I find the information provided by Miller and her colleagues to be timely and useful. The study has substantial methodological strength and should be considered seriously by those of us who, like myself, trained in an era when the reduction of a dislocated shoulder could sometimes lead to a virtual combat between the patient and a posse of orthopaedic and emergency room staff who had a minimal knowledge of pharmacology. The methods of reduction that were often used were less than atraumatic to the joint surfaces, and there was little consideration given to the potential consequences for the patient as a whole and, certainly, no consideration of the health-care system in general. Current challenges in the health-care environment demand "out of the box" thinking to promote the best patient care, safety, and the economical use of the health-care system. While many clinicians are cynical and even resentful of studies that address economic issues realistically, all clinicians have a responsibility to stay abreast of current clinical studies and to use the evidence provided by such studies to improve patient care. If these goals can be achieved by a method of treatment that is more economical, then serious consideration needs to be given accordingly to a change in practice. I commend Miller and her colleagues for both the methodology and the pertinent findings of their study, and I recommend that the method of reduction and pain-management described in their article receive serious consideration. *The author did not receive grants or outside funding in support of the research or preparation of this manuscript. He did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the author is affiliated or associated. References 1. Bhandari M, Richards RR, Sprague S, Schemitsch EH. The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000. J Bone Joint Surg Am. 2002;84:388-96. | ||||||||
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