General Obstetrics and Gynecology: Gynecology
Pain from copper intrauterine device insertion: Randomized trial of prophylactic ibuprofen

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Objectives

This study was undertaken to determine whether 400 mg of prophylactic ibuprofen can alleviate pain from insertion of an intrauterine device (IUD) and to measure level of pain with improved techniques.

Study design

We conducted a randomized, double-blind, placebo-controlled trial of 2019 first-time IUD users: 1008 women received placebo and 1011 women received 400 mg of ibuprofen. Participants took the single tablet at least 45 minutes before IUD insertion. Immediately after insertion, participants recorded level of pain by using a 10-cm visual analog scale, with the value of 10 meaning “worst imaginable pain.”

Results

Median level of pain was 1.0 for both ibuprofen and placebo participants; rank test statistics confirmed no difference. Some subgroups of women experienced higher pain (eg, nulliparous women), but ibuprofen still had no important impact on level of pain.

Conclusion

Even among first-time users, pain from IUD insertion is generally low. Prophylactic ibuprofen as used in this protocol does not reduce IUD insertion pain.

Section snippets

Materials and methods

We conducted a randomized trial of first-time IUD users to test the possible benefit of prophylactic use of ibuprofen; the main study outcome (early removal caused by bleeding and pain) and more detail on the methodology have been reported previously.24 We chose first-time IUD users to ensure fair capture/reporting of novel experiences. Briefly, eligible women were aged 18 to 49 years, literate, had menstruated in the last 6 weeks, had never used an IUD, were more than 6 weeks postpartum if

Results

Recruitment began in June 2002 and ended in August 2003. The details of recruitment and randomization (including a standardized flowchart diagram) have been reported previously.24 A total of 2019 participants were enrolled; 1011 were assigned to ibuprofen and 1008 to placebo. All participants took the first tablet as instructed before IUD insertion. One ibuprofen participant did not have information on level of pain; thus, we analyzed data on 2018 participants in total.

Overall, level of pain

Comment

We measured IUD insertion pain in more than 2000 first-time users; with a 10-point visual analog scale, we found that the mean and median levels were 1.9 and 1.0, respectively. Prophylactic ibuprofen did not affect level of pain. In subgroup analyses of participants with known high likelihood of experiencing more discomfort, ibuprofen did not alleviate pain either.

The primary conclusion from this trial is that the insertion procedure is not painful to the vast majority of women who are having

Acknowledgments

We thank the 170 Ministry of Health clinicians for recruiting/enrolling participants and for completing our forms. We also thank Laboratorios Silesia S.A. of Chile for manufacturing and bottling the placebo and ibuprofen tablets. Finally, we thank Bosny Pierre-Louis, Sandra Cameron, and Monica Salvatierra for their dedicated effort.

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    Supported by a grant from the National Institutes of Health (HD39717 to D.H.).

    The views expressed in this article do not necessarily reflect those of the authors' institutions or the funding entity.

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