Andrew Dixon1, Chantalle Clarkin2, Nick Barrowman2, Rhonda Correll2, Martin H Osmond2, Amy C Plint2. 1. Department of Pediatrics (Dixon), University of Alberta; Stollery Children's Hospital (Dixon), Edmonton, Alta.; Clinical Research Unit (Barrowman), Children's Hospital of Eastern Ontario Research Institute; Children's Hospital of Eastern Ontario Research Institute (Clarkin, Correll, Osmond, Plint), Ottawa, Ont.; Department of Pediatrics and Emergency Medicine (Osmond, Plint), University of Ottawa, Ottawa, Ont. Andrew.Dixon@AlbertaHealthServices.ca. 2. Department of Pediatrics (Dixon), University of Alberta; Stollery Children's Hospital (Dixon), Edmonton, Alta.; Clinical Research Unit (Barrowman), Children's Hospital of Eastern Ontario Research Institute; Children's Hospital of Eastern Ontario Research Institute (Clarkin, Correll, Osmond, Plint), Ottawa, Ont.; Department of Pediatrics and Emergency Medicine (Osmond, Plint), University of Ottawa, Ottawa, Ont.
Abstract
BACKGROUND:Radial-head subluxation is an easily identified and treated injury. We investigated whether triage nurses in the emergency department can safely reduce radial-head subluxation at rates that are not substantially lower than those of emergency department physicians. METHODS: We performed an open, noninferiority, cluster-randomized control trial. Children aged 6 years and younger who presented to the emergency department with a presentation consistent with radial-head subluxation and who had sustained a known injury in the previous 12 hours were assigned to either nurse-initiated or physician-initiated treatment, depending on the day. The primary outcome was the proportion of children who had a successful reduction (return to normal arm usage). We used a noninferiority margin of 10%. RESULTS: In total, 268 children were eligible for inclusion and 245 were included in the final analysis. Of the children assigned to receive physician-initiated care, 96.7% (117/121) had a successful reduction performed by a physician. Of the children assigned to receive nurse-treatment care, 84.7% (105/124) had a successful reduction performed by a nurse. The difference in the proportion of successful radial head subluxations between the groups was 12.0% (95% confidence interval [CI] 4.8% to 19.7%). Noninferiority of nurse-initiated radial head subluxation was not shown. INTERPRETATION: In this trial, the rate of successful radial-head subluxation performed by nurses was inferior to the physician success rate. Although the success rate in the nurse-initiated care group did not meet the non-inferiority margin, nurses were able to reduce radial head subluxation for almost 85% of children who presented with probable radial-head subluxation. TRIAL REGISTRATION: Clinical Trials.gov, no. NCT00993954.
RCT Entities:
BACKGROUND: Radial-head subluxation is an easily identified and treated injury. We investigated whether triage nurses in the emergency department can safely reduce radial-head subluxation at rates that are not substantially lower than those of emergency department physicians. METHODS: We performed an open, noninferiority, cluster-randomized control trial. Children aged 6 years and younger who presented to the emergency department with a presentation consistent with radial-head subluxation and who had sustained a known injury in the previous 12 hours were assigned to either nurse-initiated or physician-initiated treatment, depending on the day. The primary outcome was the proportion of children who had a successful reduction (return to normal arm usage). We used a noninferiority margin of 10%. RESULTS: In total, 268 children were eligible for inclusion and 245 were included in the final analysis. Of the children assigned to receive physician-initiated care, 96.7% (117/121) had a successful reduction performed by a physician. Of the children assigned to receive nurse-treatment care, 84.7% (105/124) had a successful reduction performed by a nurse. The difference in the proportion of successful radial head subluxations between the groups was 12.0% (95% confidence interval [CI] 4.8% to 19.7%). Noninferiority of nurse-initiated radial head subluxation was not shown. INTERPRETATION: In this trial, the rate of successful radial-head subluxation performed by nurses was inferior to the physician success rate. Although the success rate in the nurse-initiated care group did not meet the non-inferiority margin, nurses were able to reduce radial head subluxation for almost 85% of children who presented with probable radial-head subluxation. TRIAL REGISTRATION: Clinical Trials.gov, no. NCT00993954.
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