Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial

Contraception and Reproductive Medicine

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[1] 0000 0001 0421 5525, grid.265436.0, Department of Obstetrics and Gynecology, Uniformed Services University, 4301 Jones Bridge Rd, 20814, Bethesda, MD, USA;0000 0001 0560 6544, grid.414467.4, Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, 8901 Wisconsin Ave, 20889, Bethesda, MD, USA;Second Medical Group, 243 Curtiss Rd, Barksdale AFB, 71110, Louisiana, USA;

关键词: Intrauterine device;    IUD;    Pain;    Lidocaine;    NSAID;   

DOI  :  10.1186/s40834-019-0094-0

来源: publisher

【 摘 要 】

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

【 授权许可】

CC BY