Comparative efficacy of lidocaine-prilocaine cream and vaginal misoprostol in reducing pain during levonorgestrel intrauterine device insertion in women delivered only by cesarean delivery: A randomized controlled trial.

Abstract

To compare efficacy of lidocaine-prilocaine (LP) cream versus misoprostol versus placebo before levonorgestrel-releasing intrauterine device (LNG-IUD) insertion. This randomized controlled trial (RCT) was conducted in a tertiary referral hospital from April 30, 2020 to March 1, 2021 on 210 parous women willing to receive LNG-IUD and delivered only by elective cesarean delivery (CD). Participants received 200μg vaginal misoprostol or 5ml of LP cream 5% or placebo 3h before LNG-IUS insertion. Primary outcome was pain during LNG-IUD insertion, while secondary outcomes were pain 10min post-procedure, ease of insertion, patient satisfaction, insertion time, and drug side effects. Pain during LNG-IUS insertion was reduced in LP group and misoprostol group compared to placebo group (2.1±1.0 vs 3.7±1.6; p<0.001) and (2.3±1.3 vs 3.7±1.6; p<0.001), respectively. Ease of procedure and patient satisfaction were significantly higher in LP and misoprostol groups than placebo (P<0.001). Need for additional analgesia was significantly higher in placebo group than in the other two groups (P=0.009). Adverse events were not significantly different between the three groups except vomiting and abdominal cramps, which were higher with misoprostol. LP cream and 200μg of vaginal misoprostol administration before LNG-IUD insertion in women delivered only by elective CD effectively reduced pain during insertion and 10min post-procedure with easier insertions, high patient satisfaction, and tolerable side effects. Pain reduction with LP cream was clinically significant.