Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Randomized Controlled Trial Multicenter Study Clinical Trial
The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group.
In the clinical trial of diaspirin cross-linked hemoglobin (DCLHb), optimal therapy required the immediate enrollment of patients with severe, uncompensated, traumatic hemorrhagic shock. When it was not feasible to obtain prospective consent, an exception to informed consent was used according to FDA regulation 21 CFR 50.24. ⋯ Informed consent in this study of an emergent therapy most often involved the use of the consent exception and consent to continue, the latter of which occurred in a timely manner. Nearly all of those who were approached for CTC approved full participation in the study, suggesting acceptance of the process outlined in the new regulations. Patients treated in a hemorrhagic shock clinical trial may differ from the general trauma patient population.
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Randomized Controlled Trial Comparative Study Clinical Trial
A clinical trial of propofol vs midazolam for procedural sedation in a pediatric emergency department.
To compare the effectiveness, recovery time from sedation, and complication rate of propofol with those of midazolam when used for procedural sedation in the pediatric emergency department (PED). ⋯ In this study, propofol induced sedation as effectively as midazolam but with a shorter recovery time. Complication rates for propofol and midazolam were comparable, though the small study population limits the power of this comparison. Propofol may be an appropriate agent for sedation in the PED; however, further study is necessary before routine use can be recommended.
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Randomized Controlled Trial Clinical Trial
A health promotion intervention for families in a Medicaid managed care plan.
To determine whether implementation of an intervention based on a model of health promotion will encourage patients to seek care from their primary care provider (PCP) and reduce visits to the pediatric ED (PED) for minor illness. ⋯ There was no difference in health care utilization between the intervention and control groups at 12-month follow-up. The health promotion intervention did not alter utilization habits.
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Randomized Controlled Trial Clinical Trial
Octylcyanoacrylate for the treatment of partial-thickness burns in swine: a randomized, controlled experiment.
To compare re-epithelialization rates of superficial partial-thickness burns treated with octylcyanoacrylate (OCA), silver sulfadiazine (SSD), and dry gauze (controls) in swine. ⋯ Under these study conditions, treatment of partial-thickness burns with OCA spray resulted in a higher percent of re-epithelialization at seven but not 14 days when compared with both SSD and control, with no significant increase in infection rates. Future studies should evaluate the use of OCA for the treatment of burns in humans.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of topical anesthetics and vasoconstrictors vs lubricants prior to nasogastric intubation: a randomized, controlled trial.
To determine whether pre-treatment of the nose and throat with topical anesthetics and vasoconstrictors would reduce the pain associated with nasogastric (NG) intubation. ⋯ Use of topical lidocaine and phenylephrine for the nose and tetracaine with benzocaine spray for the throat prior to NG intubation results in significantly less pain and discomfort than use of a nasal surgical lubricant alone. Widespread use of topical anesthetics and vasoconstrictors prior to NG intubation is recommended.