Related Experiment Videos
Intraarterial Dexamethasone for Pain Relief After Uterine Fibroid Embolization: A Randomized Clinical Trial
Kenneth Briley1, Rohit Reddy1, Arais Cavada1
1Department of Interventional Radiology, University of Miami Miller School of Medicine, Miami, Florida.
Importance:
Acute postprocedural pain remains a major barrier to uterine fibroid embolization (UFE).
Objective:
To assess whether intraarterial dexamethasone reduces postprocedural pain after UFE.
Design, Setting, And Participants:
This double-blind, placebo-controlled randomized clinical trial was conducted from July 2020 to December 2023, with follow-up through 3 months, at a single tertiary academic medical center. Participants were women, aged 20 to 50 years, undergoing UFE.
Interventions:
Intraarterial dexamethasone (10 mg) or saline placebo administered during embolization.
Main Outcomes And Measures:
The primary outcome was postprocedural pain through 168 hours. Secondary outcomes included postembolization syndrome symptoms; fibroid-related symptoms and health-related quality of life, assessed using the UFE-Quality of Life questionnaire at baseline and at 1 and 3 months; and percentage reduction in uterine volumes on magnetic resonance imaging.
Results:
Among 42 women randomized (mean [SD] age, 44.7 [4.7] years; 21 per group), 40 women were included in the final analysis (20 randomized to the dexamethasone group and 20 to the placebo group) after excluding 2 participants. In the dexamethasone group, 7 participants (35%) were African American, 6 (30%) were Hispanic, and 7 (35%) were White; in the placebo group, 9 (45%) were African American, 8 (40%) were Hispanic, and 3 (15%) were White. Intraarterial dexamethasone was associated with significantly lower mean (SD) pain scores immediately after the procedure (4.0 [3.3] vs 6.1 [3.1]; mean difference, -2.1 [95% CI, -4.14 to -0.06]; P = .04) and through 96 hours (2.4 [2.4] vs 4.5 [3.2]; mean difference, -2.1 [95% CI, -3.90 to -0.30]; P = .02) compared with placebo. The mean (SE) pain score over 168 hours was significantly lower in the dexamethasone group vs placebo (2.63 [2.28] vs 4.28 [2.27] visual analog scale units; mean difference, -1.64 [95% CI, -3.10 to -0.19]; P = .02). Among participants with paired magnetic resonance imaging follow-up, the mean (SD) uterine volume reduction from baseline to 3 months was 37.4% (17.7%) in the dexamethasone group vs 29.6% (20.2%) in the placebo group (P = .30), and the mean (SD) dominant fibroid volume reduction was 34.4% (22.8%) vs 38.6% (16.7%) (P = .60). No major complications occurred in either group.
Conclusions And Relevance:
In this randomized clinical trial of 40 women undergoing UFE, intraarterial dexamethasone was associated with clinically meaningful reductions in postprocedural pain through 96 hours compared with placebo, without compromising treatment efficacy or increasing adverse events, which may offer a simple, low-cost strategy to reduce analgesic burden in individuals undergoing UFE.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04655144.
