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

Shana M Miles, Katerina Shvartsman, Susan Dunlow, Shana M Miles, Katerina Shvartsman, Susan Dunlow

Abstract

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

Methods: This 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.

Results: From 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.

Conclusion: Naproxen with or without intrauterine lidocaine does not reduce pain with IUD placement.

Clinical trial registration: Clinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered.

Keywords: IUD; Intrauterine device; Lidocaine; NSAID; Pain.

Conflict of interest statement

Competing interestsThe views expressed in this manuscript are those of the authors and do not reflect the official policy or position of the Department of Defense, or the U. S. Government. The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Patient enrollment and randomization to groups. Flow diagram, per Consolidated Standards of Reporting Trials. IUD, intrauterine device
Fig. 2
Fig. 2
Mean visual analog scores within 30 min of IUD insertion. Bars denote treatment groups with standard deviation. Treatment groups are lidocaine instillation and naproxen, lidocaine instillation and placebo capsule, placebo instillation and naproxen, placebo instillation and placebo capsule

References

    1. Finer Lawrence B., Henshaw Stanley K. Disparities in Rates of Unintended Pregnancy In the United States, 1994 and 2001. Perspectives on Sexual and Reproductive Health. 2006;38(2):90–96. doi: 10.1363/3809006.
    1. Trussell James. Contraceptive failure in the United States. Contraception. 2011;83(5):397–404. doi: 10.1016/j.contraception.2011.01.021.
    1. Mosher WD, Jones J. Use of contraception in the United States : 1982 – 2008 Library of Congress cataloging-in-publication data. Vital Health Stat 23. 2010. p. 1–44.
    1. Trussell James, Wynn L.L. Reducing unintended pregnancy in the United States. Contraception. 2008;77(1):1–5. doi: 10.1016/j.contraception.2007.09.001.
    1. Kuehn Bridget M. Institute of Medicine Outlines Priorities for Comparative Effectiveness Research. JAMA. 2009;302(9):936. doi: 10.1001/jama.2009.1186.
    1. Kavanaugh Megan L., Jerman Jenna. Contraceptive method use in the United States: trends and characteristics between 2008, 2012 and 2014. Contraception. 2018;97(1):14–21. doi: 10.1016/j.contraception.2017.10.003.
    1. Bracken Jennifer, Graham Cynthia A. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. The European Journal of Contraception & Reproductive Health Care. 2014;19(4):276–284. doi: 10.3109/13625187.2014.917623.
    1. MLCSGAWKL J. Myths and misconceptions about intrauterine contraception among women seeking termination of pregnancy. TT. J Fam Plan Reprod Health Care. 2013. p. 36–40.
    1. Asker Claire, Stokes-Lampard Helen, Beavan Jackie, Wilson Sue. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. Journal of Family Planning and Reproductive Health Care. 2006;32(2):89–94. doi: 10.1783/147118906776276170.
    1. Ngo Lynn L., Ward Kristy K., Mody Sheila K. Ketorolac for Pain Control With Intrauterine Device Placement. Obstetrics & Gynecology. 2015;126(1):29–36. doi: 10.1097/AOG.0000000000000912.
    1. Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006. p. 1272–7.
    1. Dijkhuizen K., Dekkers O. M., Holleboom C. A. G., de Groot C. J. M., Hellebrekers B. W. J., van Roosmalen G. J. J., Janssen C. A. H., Helmerhorst F. M. Vaginal misoprostol prior to insertion of an intrauterine device: an RCT. Human Reproduction. 2010;26(2):323–329. doi: 10.1093/humrep/deq348.
    1. Ngo Lynn L., Braaten Kari P., Eichen Eva, Fortin Jennifer, Maurer Rie, Goldberg Alisa B. Naproxen Sodium for Pain Control With Intrauterine Device Insertion. Obstetrics & Gynecology. 2016;128(6):1306–1313. doi: 10.1097/AOG.0000000000001746.
    1. Sääv I, Aronsson A, Marions L, Stephansson O, Gemzell-Danielsson K. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Hum Reprod. 2007. p. 81–4.
    1. Edelman Alison B., Schaefer Elizabeth, Olson Amanda, Van Houten Laura, Bednarek Paula, Leclair Catherine, Jensen Jeffrey T. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011;84(3):234–239. doi: 10.1016/j.contraception.2011.01.016.
    1. Origoni Massimo, Leone Roberti Maggiore Umberto, Salvatore Stefano, Candiani Massimo. Neurobiological Mechanisms of Pelvic Pain. BioMed Research International. 2014;2014:1–9. doi: 10.1155/2014/903848.
    1. Tokushige N., Markham R., Russell P., Fraser I.S. High density of small nerve fibres in the functional layer of the endometrium in women with endometriosis. Human Reproduction. 2005;21(3):782–787. doi: 10.1093/humrep/dei368.
    1. Mody Sheila K., Farala John Paul, Jimenez Berenice, Nishikawa Moena, Ngo Lynn L. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women. Obstetrics & Gynecology. 2018;132(3):575–582. doi: 10.1097/AOG.0000000000002790.
    1. Costello Michael F, Horrowitz Stephen, Steigrad Stephen, Saif Najwa, Bennett Michael, Ekangaki Abie. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertility and Sterility. 2002;78(5):1116–1122. doi: 10.1016/S0015-0282(02)03362-9.
    1. Davies Anthony, Richardson Robert E., O'Connor Hugh, Baskett Tom F., Nagele Fritz, Magos Adam L. Lignocaine aerosol spray in outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Fertility and Sterility. 1997;67(6):1019–1023. doi: 10.1016/S0015-0282(97)81433-1.
    1. Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012. p. 704–9.
    1. Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O’Brien PA, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015.
    1. Mercier Rebecca J., Zerden Matthew L. Intrauterine Anesthesia for Gynecologic Procedures. Obstetrics & Gynecology. 2012;120(3):669–677. doi: 10.1097/AOG.0b013e3182639ab5.
    1. Güney M, Oral B, Mungan T. Intrauterine lidocaine plus buccal misoprostol in the endometrial biopsy. Int J Gynecol Obstet. 2007. p. 593–8.
    1. Dogan Erbil, Celiloglu Murat, Sarihan Evrim, Demir Ahmet. Anesthetic Effect of Intrauterine Lidocaine Plus Naproxen Sodium in Endometrial Biopsy. Obstetrics & Gynecology. 2004;103(2):347–351. doi: 10.1097/01.AOG.0000109519.74229.30.
    1. Guney Mehmet, Oral Baha, Bayhan Gokhan, Mungan Tamer. Intrauterine lidocaine infusion for pain relief during saline solution infusion sonohysterography: A randomized, controlled trial. Journal of Minimally Invasive Gynecology. 2007;14(3):304–310. doi: 10.1016/j.jmig.2007.02.007.
    1. Güney Mehmet, Oral Baha, Mungan Tamer. Efficacy of Intrauterine Lidocaine for Removal of a “Lost” Intrauterine Device. Obstetrics & Gynecology. 2006;108(1):119–123. doi: 10.1097/01.AOG.0000223201.42144.80.
    1. Rowbotham MC. What is a “clinically meaningful” reduction in pain? Pain. 2001. p. 131–2.
    1. Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996. p. 485–9.
    1. Chor Julie, Bregand-White Julia, Golobof Alex, Harwood Bryna, Cowett Allison. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012;85(6):558–562. doi: 10.1016/j.contraception.2011.10.015.
    1. Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015. p. 193–7.
    1. Jensen HH, Blaabjerg J, Lyndrup J. Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion. Ugeskr Laeger. 1998;160(48):6958–6961.
    1. Davies Neal M., Anderson Keith E. Clinical Pharmacokinetics of Naproxen. Clinical Pharmacokinetics. 1997;32(4):268–293. doi: 10.2165/00003088-199732040-00002.

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