Nabih I Elkhouly1, Mohammad Ahmed Maher1. 1. a Department of Obstetrics and Gynaecology, Faculty of Medicine , Menoufia University , Shebin-Elkom , Egypt.
Abstract
OBJECTIVES: The aims of this study were to compare three different interventions to reduce pain related to insertion of the intrauterine device (IUD), namely, lidocaine, misoprostol and a non-steroidal anti-inflammatory drug, against a placebo, and to assess the advantages of one drug over another, if any. METHODS: This was an open-label randomised placebo-controlled trial of 200 women assigned to receive one of the following medications prior toIUD insertion: 10 ml 1% lidocaine paracervical block, 400 μg oral misoprostol, oral naproxen or placebo tablets. The primary outcome measure was the level of pain experienced at different steps of IUD insertion and 15 min after the procedure, measured by a visual analogue scale (VAS). RESULTS:Between July 2015 and March 2016, 208 women were invited to participate in the study: eight refused and the remaining 200 women were randomised equally into four treatment groups (50 participants in each group). All characteristics were similar between the groups. The mean pain scores recorded during speculum placement, tenaculum application, uterine sounding, IUD insertion and 15 min after insertion were similar among the four groups (p > .05). Adjuvant methods to facilitate insertion, insertion failure or device expulsion were similar between the groups (p > .05). Complications were reported in 17 participants (8.5%); all resolved spontaneously with no further management (p > .05). CONCLUSION: Despite finding that none of the study drugs seemed effective prior to IUD insertion, insertion did not cause severe pain. The negative findings indicate the need for future research into new strategies to decrease pain during IUD placement.
RCT Entities:
OBJECTIVES: The aims of this study were to compare three different interventions to reduce pain related to insertion of the intrauterine device (IUD), namely, lidocaine, misoprostol and a non-steroidal anti-inflammatory drug, against a placebo, and to assess the advantages of one drug over another, if any. METHODS: This was an open-label randomised placebo-controlled trial of 200 women assigned to receive one of the following medications prior to IUD insertion: 10 ml 1% lidocaine paracervical block, 400 μg oral misoprostol, oral naproxen or placebo tablets. The primary outcome measure was the level of pain experienced at different steps of IUD insertion and 15 min after the procedure, measured by a visual analogue scale (VAS). RESULTS: Between July 2015 and March 2016, 208 women were invited to participate in the study: eight refused and the remaining 200 women were randomised equally into four treatment groups (50 participants in each group). All characteristics were similar between the groups. The mean pain scores recorded during speculum placement, tenaculum application, uterine sounding, IUD insertion and 15 min after insertion were similar among the four groups (p > .05). Adjuvant methods to facilitate insertion, insertion failure or device expulsion were similar between the groups (p > .05). Complications were reported in 17 participants (8.5%); all resolved spontaneously with no further management (p > .05). CONCLUSION: Despite finding that none of the study drugs seemed effective prior to IUD insertion, insertion did not cause severe pain. The negative findings indicate the need for future research into new strategies to decrease pain during IUD placement.