A prospective, randomized, double-blind study comparing the efficacy of diltiazem, glyceryl trinitrate, and lidocaine for the treatment of anal fissure in children.

PURPOSE: Anal fissure (AF) is a common perianal condition in children. Although adult patients with AF have been treated successfully using diltiazem, it has not been studied in children. The present randomized, prospective, double-blind study assessed the response, side effects, and recurrence of diltiazem.

METHODS

Ninety-three children with AF were randomly divided into three groups. Each group received topical ointment. Group GTN received 0.2% glyceryl trinitrate, group L received 10% lidocaine, and group D received 2% diltiazem ointment.

RESULTS

Eighty-two patients completed the 12-month study. At the end of the first 8-week course, the healing rate in group D was significantly higher than that of the other groups (p < 0.0001, χ (2) = 19.82). Nonresponders received a second course of the same treatment. Group D showed significantly higher healing rates than the other groups (p < 0.05, χ (2) = 7.227) at the end of the second 8-week course. The group D recurrence rate was significantly different than that of the other groups (p < 0. 002, χ (2) = 12.79).

CONCLUSION

Diltiazem application is effective and safe for the treatment of AF in children, and has a low recurrence rate. The smooth dose-concentration curve causes minimal side effects.