Multidose Ibuprofen Prior to Intrauterine device insertion (MIPI): a triple blinded randomized controlled trial.

Abstract

Intrauterine device insertion is often associated with moderate to severe pain, which poses a substantial barrier to its widespread use. While single-dose ibuprofen has shown limited efficacy, its pharmacokinetics suggest a multidose, preemptive approach might be more effective by achieving sustained therapeutic concentrations. To determine if a preemptive, multidose ibuprofen regimen reduces pain during intrauterine device insertion, decreases pain levels 24 hours postinsertion, and minimizes the need for additional pain relief within 24 hours after insertion. We conducted a triple-masked, randomized controlled trial. Participants were randomized to receive 3 doses of ibuprofen 800 mg or placebo over approximately 24 hours before intrauterine device insertion. The primary outcome was pain severity during intrauterine device insertion, measured by the 0 to 10 Numeric Pain Rating Scale. Secondary outcomes included 24-hour postinsertion pain and use of additional pain relief. We targeted 34 participants per group (total 68) for 80% power, analyzing data via intention to treat. Ibuprofen superiority was defined as a ≥30% reduction in mean Numeric Pain Rating Scale levels compared to placebo. The primary outcome was compared between the ibuprofen and placebo groups using the Mann-Whitney U test (for non-normally distributed data), Chi-square testing, and Fisher's exact test. Eighty-three participants agreed to participate and were randomized, with 42 assigned to placebo and 41 to ibuprofen. Of these, 66 participants presented for and underwent intrauterine device insertion. Insertion-related pain was substantial, with 39.4% (26/66) reporting severe pain and 42.4% (28/66) reporting moderate pain. Participants receiving preemptive multidose ibuprofen experienced significantly lower insertion pain compared with placebo (median Numeric Pain Rating Scale 5 [interquartile range, 4-7] vs 7 [interquartile range, 5-8], P=.01), representing a clinically and statistically meaningful difference. Follow-up data at 24 hours postinsertion were available for 80.3% (53/66) of participants. At 24 hours, there were no significant differences between groups in pain severity (P=.96) or use of additional analgesia (P=.76). Compared to placebo, a preemptive multidose ibuprofen regimen significantly (P=.01) reduces pain during intrauterine device insertion.