Stephanie O Ibemere1, Sarah B Dubbs2, Huiman X Barnhart3, Jacqueline L Brown4, Caroline E Freiermuth5, Patricia Kavanagh6, Judith A Paice7, John J Strouse8, R Gentry Wilkerson2, Paula Tanabe9. 1. School of Nursing, Duke University, Durham, NC 27710, United States of America. Electronic address: stephanie.ibemere@duke.edu. 2. Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, United States of America. 3. Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University, Durham, NC, 27710, United States of America. 4. School of Nursing, Duke University, Durham, NC 27710, United States of America. 5. Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH 45267, United States of America. 6. Division of General Pediatrics, Boston University School of Medicine/Boston Medical Center, Boston, MA 02118, United States of America. 7. Division of Hematology-Oncology, Northwestern University; Feinberg School of Medicine, Chicago, IL 606011, United States of America. 8. Division of Hematology, Department of Medicine, and Division of Pediatric Hematology/Oncology, Department of Pediatrics, Duke University School of Medicine, Durham, NC 27710, United States of America. 9. Schools of Nursing and Medicine, Duke University, Durham, NC 27710, United States of America.
Abstract
OBJECTIVES: Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations for VOE treatment are based primarily on expert opinion. In this randomized controlled trial (RCT), we will compare changes in pain scores between patients randomized to a patient-specific analgesic protocol versus those randomized to a weight-based analgesic protocol, as recommended by the NHLBI guidelines. METHODS: We report the rationale and design of a multi-site, phase III, single-blinded, RCT to be conducted in six EDs in the United States. Eligible participants will be randomized after providing consent, anticipating 50% of those randomized would have an ED visit during the enrollment period. A total of 230 participants with one VOE ED visit provides sufficient power to detect a clinically significant difference in pain score reductions of 14 between groups with 0.05 type I error. Uniquely, this trial randomizes participants in a larger population than the study population, given the impossibility of consenting and randomizing participants during emergencies. The primary endpoint is the change in pain scores in the ED from time of placement in treatment area to time of disposition (hospitalization, discharged home, or assigned to observation status) or a maximum treatment duration of 6 hours. Additional outcomes include hospitalizations and ED visits seven days post enrollment, side effects, and safety assessments. CONCLUSIONS: The COMPARE-VOE study design will provide high-level evidence to support the NHLBI VOE treatment guidelines.
OBJECTIVES: Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations for VOE treatment are based primarily on expert opinion. In this randomized controlled trial (RCT), we will compare changes in pain scores between patients randomized to a patient-specific analgesic protocol versus those randomized to a weight-based analgesic protocol, as recommended by the NHLBI guidelines. METHODS: We report the rationale and design of a multi-site, phase III, single-blinded, RCT to be conducted in six EDs in the United States. Eligible participants will be randomized after providing consent, anticipating 50% of those randomized would have an ED visit during the enrollment period. A total of 230 participants with one VOE ED visit provides sufficient power to detect a clinically significant difference in pain score reductions of 14 between groups with 0.05 type I error. Uniquely, this trial randomizes participants in a larger population than the study population, given the impossibility of consenting and randomizing participants during emergencies. The primary endpoint is the change in pain scores in the ED from time of placement in treatment area to time of disposition (hospitalization, discharged home, or assigned to observation status) or a maximum treatment duration of 6 hours. Additional outcomes include hospitalizations and ED visits seven days post enrollment, side effects, and safety assessments. CONCLUSIONS: The COMPARE-VOE study design will provide high-level evidence to support the NHLBI VOE treatment guidelines.
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