Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery

NCT04198233 ↗

Phase 4 Unknown 130 enrolled TriHealth Inc.

RandomizedParallel-groupTriple-blindSupportive care

Summary

This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6 hours postoperative compared to placebo.

Timeline

Start: 2020-02-12
Primary completion: 2022-05
Completion: 2022-12

Publications

Aldrich ER, Tam TY, Saylor LM, Crisp CC, Yeung J, Pauls RN. Intrarectal diazepam following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):302.e1-302.e9. doi: 10.1016/j.ajog.2022.05.009. Epub 2022 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diazepam	Small molecule	10 mg	Rectal

Indications

No indication recorded.