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, stool softeners, and analgesic ointments. However, some cases are intractable to the treatment. In recent years, it has been reported that nitric oxide donors such as local glyceryl-trinitrate (GTN) ointment causes a reversible chemical sphincterotomy. Although the GTN ointment can be an alternative therapy for adult cases, it has not yet been studied in the children who suffer 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 contained either 0.2% GTN, 10% lidocaine, or placebo. These ointments were applied to the lowest part of the anal canal twice daily. Patients were periodically reviewed, and the study was ended after 8 weeks. RESULTS: Complete healing of the fissure occurred in 26 of 31 (83.9%) patients treated with GTN, 7 of 14 (50%) patients treated with lidocaine, and 6 of 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 statistically significant (P < .001). CONCLUSION: The majority of children suffering from anal fissure will be cured and have relief of symptoms after topical application of GTN ointment to the anal canal.