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Randomized Controlled Trial Comparative Study
A randomized controlled trial comparing two vaso-occlusive episode (VOE) protocols in sickle cell disease (SCD).
- Paula Tanabe, Susan Silva, Hayden B Bosworth, Regina Crawford, Judith A Paice, Lynne D Richardson, Christopher N Miller, and Jeffrey Glassberg.
- Duke University School of Nursing and Medicine.
- Am. J. Hematol. 2018 Feb 1; 93 (2): 159-168.
AbstractLimited evidence guides opioid dosing strategies for acute Sickle Cell (SCD) pain. We compared two National Heart, Lung and Blood (NHBLI) recommended opioid dosing strategies (weight-based vs. patient-specific) for ED treatment of acute vaso-occlusive episodes (VOE). A prospective randomized controlled trial (RCT) was conducted in two ED's. Adults ≥ 21 years of age with SCD disease were eligible. Among the 155 eligible patients, 106 consented and 52 had eligible visits. Patients were pre-enrolled in the outpatient setting and randomized to one of two opioid dosing strategies for a future ED visit. ED providers accessed protocols through the electronic medical record. Change in pain score (0-100 mm VAS) from arrival to ED disposition, as well as side effects were assessed. 52 patients (median age was 27 years, 42% were female, and 89% black) had one or more ED visits for a VOE (total of 126 ED study visits, up to 5 visits/patient were included). Participants randomized to the patient-specific protocol experienced a mean reduction in pain score that was 16.6 points greater than patients randomized to the weight-based group (mean difference 95% CI = 11.3 to 21.9, P = 0.03). Naloxone was not required for either protocol and nausea and/or vomiting was observed less often in the patient-specific protocol (25.8% vs 59.4%, P = 0.0001). The hospital admission rate for VOE was lower for patients in the patient-specific protocol (40.3% vs 57.8% P = 0.05). NHLBI guideline-based analgesia with patient-specific opioid dosing resulted in greater improvements in the pain experience compared to a weight-based strategy, without increased side effects.© 2017 Wiley Periodicals, Inc.
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