دورية أكاديمية
Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial.
| العنوان: | Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial. |
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| المؤلفون: | Smid MC; Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, The Ohio State University, Columbus, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, University of Pittsburgh, Pittsburgh, Pennsylvania, University of Alabama at Birmingham, Birmingham, Alabama, Brown University, Providence, Rhode Island, Columbia University, New York, New York, University of Texas Medical Branch, Galveston, Texas, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Northwestern University, Chicago, Illinois, and University of Texas at Austin, Austin, Texas; the Department of Anesthesiology, Columbia University, New York, New York; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland., Clifton RG, Rood K, Srinivas S, Simhan HN, Casey BM, Longo M, Landau R, MacPherson C, Bartholomew A, Sowles A, Reddy UM, Rouse DJ, Bailit JL, Thorp JM Jr, Chauhan SP, Saade GR, Grobman WA, Macones GA |
| مؤلفون مشاركون: | for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network* |
| المصدر: | Obstetrics and gynecology [Obstet Gynecol] 2024 Aug 01; Vol. 144 (2), pp. 195-205. Date of Electronic Publication: 2024 Jun 10. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial; Equivalence Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0401101 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-233X (Electronic) Linking ISSN: 00297844 NLM ISO Abbreviation: Obstet Gynecol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2004- : Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: New York. |
| مواضيع طبية MeSH: | Analgesics, Opioid*/therapeutic use , Analgesics, Opioid*/administration & dosage , Cesarean Section* , Pain, Postoperative*/drug therapy, Humans ; Female ; Pregnancy ; Adult ; Decision Making, Shared ; Pain Management/methods |
| مستخلص: | Objective: To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management. Methods: In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets. Results: From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum. Conclusion: Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge. Clinical Trial Registration: ClinicalTrials.gov, NCT04296396. Competing Interests: Financial Disclosure Unrelated to this work, Marcela C. Smid reports that she serves as a consultant for Gilead Science Inc and Alydia/Organon. Her institution receives research funding from both organizations. Rebecca Clifton reports payment from the University of Arkansas for Medical Sciences for DSMB reviews. Sindhu Srinivas reports receiving payments from Goodall, Decries, Leech & Dawn, LLP, and Huff Powell Bailey. Ruth Landau reports receiving payments from PACIRA Biosciences and Regional Anesthesia and Pain Medicine. Cora MacPherson reports receiving payments from PCORI and Natera. The other authors did not report any potential conflicts of interest. (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.) |
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| معلومات مُعتمدة: | UG1 HD027869 United States HD NICHD NIH HHS; UG1 HD040560 United States HD NICHD NIH HHS; UG1 HD040545 United States HD NICHD NIH HHS; UG1 HD040485 United States HD NICHD NIH HHS; UG1 HD040500 United States HD NICHD NIH HHS; U24 HD036801 United States HD NICHD NIH HHS; UG1 HD052097 National Institute of Child Health and Human Development; UG1 HD087230 United States HD NICHD NIH HHS; UG1 HD027915 United States HD NICHD NIH HHS; UG1 HD087192 United States HD NICHD NIH HHS; UG1 HD040544 United States HD NICHD NIH HHS; UG1 HD034208 United States HD NICHD NIH HHS; UG1 HD040512 United States HD NICHD NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04296396 |
| المشرفين على المادة: | 0 (Analgesics, Opioid) |
| تواريخ الأحداث: | Date Created: 20240610 Date Completed: 20240718 Latest Revision: 20240720 |
| رمز التحديث: | 20240720 |
| مُعرف محوري في PubMed: | PMC11257794 |
| DOI: | 10.1097/AOG.0000000000005649 |
| PMID: | 38857509 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-233X |
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| DOI: | 10.1097/AOG.0000000000005649 |