Many studies have been conducted to evaluate pain control options for intrauterine device (IUD) placement. However, few interventions have proven effective at reducing pain, including the NSAID ibuprofen. Prior studies on naproxen sodium, another NSAID, suggest effective pain relief. However, these studies were conducted among women having IUDs inserted that are different shapes and sizes than those available in the United States today. Thus, it is not clear if the results of those studies can be applied to current IUDs and today’s practice.
Statement of purpose
This study compared oral naproxen sodium versus placebo to better elucidate the effect of naproxen sodium on pain control with insertion of modern IUDs.
Basic description of methodology
This was a randomized, double-blind, placebo controlled trial. Patients received either 550mg oral naproxen sodium or placebo one hour prior to IUD placement. The primary outcome was pain with IUD insertion measured on a 100mm visual analogue scale (VAS). Our sample size was calculated to detect a 15mm difference in VAS scores with 80% power (α = 0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes post-insertion. A total of 118 women were enrolled and analyzed (58 in the naproxen arm, 60 in the placebo arm, 97% nulliparous) between May 2015 and March 2016.
There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in pain scores between the naproxen sodium arm compared to the placebo arm with IUD insertion (median VAS 69 mm versus 66 mm, p = 0.89), tenaculum placement (37 mm versus 32 mm, p = 0.97), or uterine sounding (60 mm versus 58 mm, p = 0.66). Post-procedure pain scores were lower in the naproxen arm as compared to the placebo arm: 17 mm versus 26 mm, (p = 0.01) at 5 minutes and 13 mm versus 24 mm, (p = 0.01) at 15 minutes.
Conclusion/summary statement about relevance
Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication.