Sildenafil in Emergency Treatment of Biliary Colic: A pilot randomized controlled trial

Abstract

Abstract Background: Sildenafil was reported to have a strong inhibitory effect on both gallbladdercontraction and biliary pressure of the Sphincter of Oddi. We hypothesized that a single oral dose of sildenafil might counteract the smooth muscle spasm and decrease the intra-ductal and sphincteric pressures to relieve pain of biliary colic and facilitate release of impacted stones. We aimed to assess the pain-relieving effect of 25 mg oral Sildenafil dose in comparison to an oral 20 mg ketorolac dose in adult patients presenting with acute biliary colic. Methods: Twenty consecutive eligible patients presenting with moderate to severe biliary colic were randomly assigned to receive one Sildenafil 25 mg tablet or two ketorolac 10 mg oral tablets. A four point’s verbal rating scale (VRS) and 100 mm Visual pain analog scale (VPAS) of pain severity were measured before treatment then at 30 and 60 minutes after the dose intake. Results: Treatment success, defined as reduction of VRS, 60 minutes after dose intake from moderate and severe to mild or none was similar (9/10) in both treatment groups. Significant reductions of VPAS at 30 and 60 minutes were noted in both groups. The reduction in VPAS after 60 minutes from dose intake was significantly greater in Sildenafil group (83.16%) than ketorolac group (79.34%) (p=0.033). Conclusions: Single oral dose of sildenafil 25 mg might be safe and effective for relief of biliary colic. Further studies are needed to confirm its value particularly for patients who cannot tolerate or show inadequate response to analgesics or opiates. Trial Registration Id: ACTRN12619001388101 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378014&isReview=true (retrospectively registered)