Double-Blinded, Randomized, Placebo-Controlled Trial of Multimodal Analgesia at Intrauterine Device Insertion [15I

Abstract

INTRODUCTION: The utilization of long acting reversible contraception has remained low. Pain and anxiety associated with intrauterine device (IUD) placement are barriers. The purpose of this study was to investigate the effects of cervical lidocaine injections and oral diazepam on pain and anxiety during office IUD insertion. METHODS: Following Institutional Review Board approval, subjects desiring IUD placement were randomized to diazepam 5 mg orally with cervical injections of 2.5 ml of 2% lidocaine or placebo pill with saline injections. Both groups received 800 mg oral Ibuprofen. Providers and subjects were blinded to their assigned group. Primary outcome was pain on a visual analog scale at various steps of IUD insertion. Power analysis set enrollment at 58, which is ongoing. RESULTS: At interim analysis, a total of 41 women have been enrolled. Of these, 39 (20 in the study arm, 19 in the placebo arm) underwent IUD insertion. Median anxiety was significantly decreased when placing the speculum in the study arm compared to placebo (5.5 mm vs. 31 mm; P=.004) respectively. Additionally, subjects in the intervention group reported lower pain scores during insertion of the IUD (24 mm vs. 71 mm, P=.030). CONCLUSION: At interim analysis, oral diazepam and cervical lidocaine injections compared to placebo show clinically significant decreases in anxiety and pain during IUD placement. If these early results are confirmed, the use of cervical lidocaine injections and oral diazepam may provide additional tools to help increase utilization of IUDs by decreasing pain and anxiety associated with insertion.