Abstract
Purpose: Uterine fibroid embolization (UFE) is associated with post-procedural pain and nausea. In this double-blind randomized controlled study, we compared pre-procedure intravenous (IV) acetaminophen/ibuprofen to postprocedure IV ketorolac in UFE patients. Methods: After institutional review board approval, UFE candidates 21-60 years old were screened and randomly assigned to one of four arms: acetaminophen (1 g), ibuprofen (800 mg), acetaminophen (1 g) and ibuprofen (800 mg) combined, and an active comparator, ketorolac (30 mg). All received rescue patient-controlled hydromorphone for 24 h post-procedure. Primary outcome was measurement of pain intensity (visual analog scale: VAS) between the acetaminophen/ibuprofen group and the ketorolac group. The secondary outcomes were opioid and anti-emetic requirements and nausea intensity (VAS). Results: 40 subjects were analysed: acetaminophen/ ibuprofen (N=16); acetaminophen (N=4); ibuprofen (N=4); ketorolac (N=16). The maximum and mean VAS scores for pain were not different between the acetaminophen/ ibuprofen group and the ketorolac group without adjusting for opioid consumption (p=0.243 and p=0.208, respectively). Total opioid consumption in morphine equivalents (mean [±SE]) was 28.09 mg (±4.58) in the acetaminophen/ibuprofen group and 40.33 mg (±7.79) in the ketorolac group (p=0.087), demonstrating a trend favouring the acetaminophen/ibuprofen group. The mean and maximum nausea scores showed a trend and significant difference (p=0.095 and p=0.003), respectively, favouring the ketorolac group. Conclusion: IV acetaminophen/ibuprofen demonstrated comparable pain control, although there was less opioid requirement for the acetaminophen/ibuprofen group compared to the ketorolac group. Maximum nausea scores were significantly increased with similar ondansetron requirements. Therefore, antiemetic prophylaxis is needed regardless of group.
Highlights
Over 70% of women develop fibroids [1], which may be associated with bulk symptoms such as urinary discomfort and pelvic pain, as well as excessive menstrual bleeding [2]
uterine fibroid embolization (UFE) is associated with post-embolization syndrome, which includes post-procedure pain and nausea [6,7]
Due to the introduction of newly developed modalities such as radial artery entry, superior hypo gastric nerve block, intra-arterial lidocaine injection, and dexamethasone, which have demonstrated an improvement in patient satisfaction, pain control, and opioid sparing effects after UFEs, we decided to terminate the study after the interim analysis and analyse the data as if it were the final study [18,19,20,21]
Summary
Over 70% of women develop fibroids [1], which may be associated with bulk symptoms such as urinary discomfort and pelvic pain, as well as excessive menstrual bleeding [2]. Symptomatic uterine fibroids are the most common etiology for hysterectomy in the United States [3]. A non-surgical, minimally invasive treatment option such as uterine fibroid embolization (UFE), has proven to be a successful alternative to hysterectomy [4,5]. UFE is associated with post-embolization syndrome, which includes post-procedure pain and nausea [6,7]. The etiology of the discomfort is explained by the resultant ischemia and inflammation of the myometrium following embolization [8].
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