ClinicalTrials.gov, NCT02219308.

Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement.