Rebecca H Allen1, Christina Raker, Vinita Goyal. 1. Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI 02905, USA. Electronic address: rhallen@wihri.org.
Abstract
OBJECTIVE: To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion. STUDY DESIGN: This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first-time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test. RESULTS: Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36) in the placebo group (p=.8). CONCLUSIONS: Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. IMPLICATIONS: Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel.
RCT Entities:
OBJECTIVE: To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion. STUDY DESIGN: This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first-time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test. RESULTS: Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36) in the placebo group (p=.8). CONCLUSIONS: Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel. IMPLICATIONS: Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel.
Authors: Katherine L O'Flynn O'Brien; Aletha Y Akers; Lisa K Perriera; Courtney A Schreiber; J Felipe Garcia-Espana; Sarita Sonalkar Journal: J Pediatr Adolesc Gynecol Date: 2019-01-08 Impact factor: 1.814
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