Abstract

BackgroundThis study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo.MethodsThis was a randomized, double-blind, placebo-controlled trial. Patients desiring levonorgestrel 52 mg IUD or Copper T380A IUD were randomized into treatment groups. Patients received either oral naproxen 375 mg or placebo approximately 1 h prior to procedure in conjunction with 5 mL of 2% lidocaine or 5 mL of intrauterine saline. The primary outcome was pain with IUD insertion measured on a visual analog scale immediately following the procedure. Prespecified secondary outcomes included physician pain assessment, post procedure analgesia, satisfaction with procedure, satisfaction with IUD, and pain assessment related to IUD type.ResultsFrom June 4, 2014 to October 28, 2016 a total of 160 women desiring Copper T380A or levonorgestrel 52 mg intrauterine device insertion and meeting study criteria were enrolled and randomized in the study. Of these, 157 (78 in the Copper T380A arm, 79 in the levonorgestrel 52 mg) received study treatment medication. There were 39 in naproxen/lidocaine arm, 39 in placebo/lidocaine arm, 40 in naproxen/placebo arm, and 39 in placebo/placebo arm. There were no differences in the mean pain scores for IUD placement between treatment groups (naproxen/lidocaine 3.38 ± 2.49; lidocaine only 2.87 ± 2.13; naproxen only 3.09 ± 2.18; placebo 3.62 ± 2.45). There was no difference in self-medication post procedure or in satisfaction with the procedure and IUD among women in the treatment arms or by type of IUD.ConclusionNaproxen with or without intrauterine lidocaine does not reduce pain with IUD placement.Clinical trial registrationClinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered

Highlights

  • This study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo

  • There were 160 women enrolled in the study between June 2014 and October 2016, with 80 desiring the levonorgestrel 52 mg IUD and 80 desiring Copper T380A IUD with 40 randomized in each treatment arm

  • Enrollment was closed for either levonorgestrel 52 mg IUD or Copper T380A IUD after 80 women were enrolled in each respective arm

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Summary

Introduction

This study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo. Intrauterine devices (IUDs) are among the most effective longacting reversible contraceptives [4]. Five IUDs are available in the United States: the Copper T380A (Paragard), levonorgestrel 52 mg (Mirena), levonorgestrel 52 mg (Liletta), levonorgestrel 19.5 mg (Kyleena) and levonorgestrel 13.5 mg (Skyla). While IUD and contraceptive implant use has grown over the past decade, the current usage is only 14% in the United States [6]. One of the barriers to IUD insertion is discomfort, or anticipation of pain, during device insertion [7,8,9]. Adequate pain control during gynecologic outpatient office procedures including hysterosalpingography, endometrial biopsy, and IUD

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