Rachel B Rapkin1, Sharon L Achilles, E Bimla Schwarz, Leslie Meyn, Miriam Cremer, Christy M Boraas, Beatrice A Chen. 1. Department of Obstetrics and Gynecology, University of South Florida, Tampa, Florida; the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, and Magee-Womens Research Institute, Pittsburgh, Pennsylvania; the Department of Medicine, University of California, Davis, Sacramento, California; the Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio; and the Department of Obstetrics, Gynecology, and Women's Health, University of Minnesota, Minneapolis, Minnesota.
Abstract
OBJECTIVE: To evaluate self-administration of vaginal lidocaine gel to decrease pain with intrauterine device (IUD) insertion in nulliparous women. METHODS: In this randomized, double-blind, placebo-controlled trial, women self-administered 2% lidocaine or placebo vaginal gel 5 minutes before IUD insertion. The primary outcome was change in pain from baseline to IUD insertion on a 100-mm visual analog scale. We also assessed pain after speculum insertion, tenaculum placement, uterine sounding, and 5 minutes after IUD insertion. Secondary outcomes included patient acceptability, ease of IUD insertion, and need for pain medication for up to 7 days. RESULTS:From July 2012 to May 2013, 59 women were randomized; 30 receivedlidocaine gel and 29 placebo. Baseline demographics, including age, race, and body mass index, were similar. There was no difference in median change in pain during IUD insertion in women receiving lidocaine (61 mm [interquartile range 53-71]) compared with placebo (69 mm [interquartile range 63-80], P=.06). Women receiving lidocaine experienced less pain with tenaculum placement (32 mm [interquartile range 18-54]) compared with placebo (56 mm [interquartile range 26-75], P=.02). Most (76%) women were satisfied with their IUD insertion experience and 86% would probably or definitely recommend an IUD to a friend. Thirty-four percent of women required pain medication for at least 3 days after IUD insertion. CONCLUSION: For nulliparous women, self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, but does decrease pain with tenaculum placement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01534520.
RCT Entities:
OBJECTIVE: To evaluate self-administration of vaginal lidocaine gel to decrease pain with intrauterine device (IUD) insertion in nulliparous women. METHODS: In this randomized, double-blind, placebo-controlled trial, women self-administered 2% lidocaine or placebo vaginal gel 5 minutes before IUD insertion. The primary outcome was change in pain from baseline to IUD insertion on a 100-mm visual analog scale. We also assessed pain after speculum insertion, tenaculum placement, uterine sounding, and 5 minutes after IUD insertion. Secondary outcomes included patient acceptability, ease of IUD insertion, and need for pain medication for up to 7 days. RESULTS: From July 2012 to May 2013, 59 women were randomized; 30 received lidocaine gel and 29 placebo. Baseline demographics, including age, race, and body mass index, were similar. There was no difference in median change in pain during IUD insertion in women receiving lidocaine (61 mm [interquartile range 53-71]) compared with placebo (69 mm [interquartile range 63-80], P=.06). Women receiving lidocaine experienced less pain with tenaculum placement (32 mm [interquartile range 18-54]) compared with placebo (56 mm [interquartile range 26-75], P=.02). Most (76%) women were satisfied with their IUD insertion experience and 86% would probably or definitely recommend an IUD to a friend. Thirty-four percent of women required pain medication for at least 3 days after IUD insertion. CONCLUSION: For nulliparous women, self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, but does decrease pain with tenaculum placement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01534520.
Authors: Aletha Y Akers; Jennifer Harding; Lisa K Perriera; Courtney Schreiber; J Felipe Garcia-Espana; Sarita Sonalkar Journal: Obstet Gynecol Date: 2018-06 Impact factor: 7.661
Authors: Laureen M Lopez; Alissa Bernholc; Yanwu Zeng; Rebecca H Allen; Deborah Bartz; Paul A O'Brien; David Hubacher Journal: Cochrane Database Syst Rev Date: 2015-07-29