General Obstetrics and Gynecology: GynecologyPain from copper intrauterine device insertion: Randomized trial of prophylactic ibuprofen
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.
References (29)
- et al.
Intrauterine devices and pelvic inflammatory disease: an international perspective
Lancet
(1992) - et al.
Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials
Contraception
(1999) - et al.
Contraceptive efficacy of the copper T 380A and copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries
Contraception
(1994) - et al.
Severe pain at interval IUD insertion: a case-control analysis of patient risk factors
Contraception
(1986) - et al.
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
Lancet
(2001) - et al.
Analgesia for colposcopy: double-masked, randomized comparison of ibuprofen and benzocaine gel
Obstet Gynecol
(2001) - United Nations. Department of Economic and Social Affairs. World Contraceptive Use 2003. Available at:...
Pain control during insertion of an intrauterine device
Br J Fam Plann
(1995)- et al.
Use of contraception and use of family planning services in the United States: 1982-2002
Adv Data
(2004) - Population Reference Bureau. Family Planning Worldwide 2002 Data Sheet. Available at:...
Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women
N Engl J Med
Contraceptive efficacy of the copper T380A and the multiload Cu250 IUD in three developing countries
Adv Contracept
Comparative study of safety and efficacy of IUD insertions by physicians and nursing personnel in Brazil
Bull Pan Am Health Organ
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Supported by a grant from the National Institutes of Health (HD39717 to D.H.).
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