A prospective, randomized, double-blind, placebo-controlled trial of glyceryl-trinitrate ointment in the treatment of children with anal fissure

Background: Anal fissure in children usually is treated by sitz baths, stoo l softeners, and analgesic ointments. However, some cases are intractable t o the treatment. In recent years, it has been reported that nitric oxide do nors such as local glyceryl-trinitrate (GTN) ointment causes a reversible c hemical sphincterotomy. Although the GTN ointment can be an alternative the rapy for adult cases, it has not yet been studied in the children who suffe r from anal fissure. Methods: Sixty-five children with anal fissure were divided randomly into 3 groups. Each group received double-blinded a topical ointment that contain ed either 0.2% GTN, 10% lidocain, or placebo. These ointments were applied to the lowest part of the anal canal twice daily. Patients were periodicall y reviewed, and the study was ended after 8 weeks. Results: Complete healing of the fissure occurred in 26 of 31 (83.9%) patie nts treated with GTN, 7 of 14 (50%) patients treated with lidocain, and 6 o f 17 (35.2%) treated with placebo. In 29 of 31 (93.5%) GTN-treated patients , a total relief of symptoms was observed, whereas this occurred in 7 of 14 (50%) treated with lidocaine and 6 of 11 (35.3%) in the placebo group. The differences between the study group and control groups were highly statist ically significant (P < .001). Conclusion: The majority of children suffering from anal fissure will be cu red and have relief of symptoms after topical application of GTN ointment t o the anal canal. J Pediatr Surg 34:1810-1812. Copyright (C) 1999 by W.B. S aunders Company.