Session: 114. Sickle Cell Disease, Sickle Cell Trait, and Other Hemoglobinopathies, Excluding Thalassemias: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Research, Sickle Cell Disease, Clinical Research, Hemoglobinopathies, Supportive Care, Diseases, Treatment Considerations
Methods: Prospective, single institution, observational study evaluating CAYAs with SCD aged 3-26 years hospitalized at Riley Hospital for Children with acute SCD pain. Approval was obtained from the Indiana University Institutional Review Board. Interim analysis included data obtained April 2024-June 2024. All patients received standard-of-care pharmacologic pain management. Patients with acute SCD pain were offered OMT. Written informed consent/assent were obtained. OMT was provided by a board-certified osteopathic physician. Safety was assessed by adverse event grading per Common Terminology Criteria for Adverse Events. Feasibility was defined as completion of an OMT encounter without interruption to standard inpatient care. Pain was assessed with validated FACES pain scores. Constipation was assessed with a validated Bristol Stool Scale. Total oral morphine milligram equivalents (MME), total number of doses of as-needed analgesics and laxatives, and total number of bowel movements within 24 hours of OMT were collected. A non-validated questionnaire was used to assess patient interest in future OMT. Analysis of safety, feasibility, and patient-reported outcome survey data were reported with descriptive statistics.
Results: At interim analysis, 6 patients were screened and received OMT. The majority of patients were female (n=4, 66.7%) with median age of 16 years at time of OMT (range 10-19 years). Patients had HbSS (n=4, 66.7%) or HbS-beta thalassemia plus (n=2, 33.3%). All OMT encounters were completed without interruption to standard inpatient care. There were no reported adverse events within 24 hours of OMT. Immediately after OMT, FACES scores were decreased (n=3, 50%) or unchanged (n=3, 50%) in all encounters. Total oral MME decreased after OMT in the majority of cases (n=5, 83.3%). Of these cases, median oral MME decreased from 161mg to 132mg. Total laxative doses were decreased (n=3, 50%) or unchanged (n=3, 50%) in all encounters. Two patients had bowel movements within 24 hours of OMT after not having a bowel movement in the 24 hours prior. The majority of patients (n=5, 83.3%) reported interest in receiving OMT as part of future pain management.
Conclusion: At interim analysis, in this cohort of CAYAs with SCD hospitalized with acute SCD pain, OMT was well tolerated with no attributable adverse events. OMT was beneficial, with improvements in constipation and pain, as well as decreased cumulative opioid requirement in the majority of cases. These trends toward efficacy are promising and support continued investigation of OMT as a potential novel adjunctive therapy for SCD pain management.
Disclosures: No relevant conflicts of interest to declare.