Opioid Prescription After Cesarean Trial

Summary

Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.

Timeline

Start

2020-09-21

Primary completion

2022-04-07

Completion

2022-07-08

Outcome

Met primary endpoint

paper 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) PMID 38857509 ↗

Publications

• Smid MC, 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; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Aug 1;144(2):195-205. doi: 10.1097/AOG.0000000000005649. Epub 2024 Jun 10.

Drugs

Indications