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

BACKGROUND

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.

OBJECTIVE

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.

STUDY

DESIGN

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.

RESULTS

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).

CONCLUSION

Compared to placebo, a preemptive multidose ibuprofen regimen significantly (P=.01) reduces pain during intrauterine device insertion.