Randomized, placebo-controlled treatment of anal fissure by lidocaine, EMLA, and GTN in children

Abstract

Background/Purpose: Anal fissures would result in constipation in children, worsening the clinical picture, thus, justifying a fast response therapy. In this randomized, prospective, placebo-controlled study, it was aimed to determine the response rates to fissure treatment by lidocaine, EMLA and GTN on the 10th day and after 8 weeks of therapy. Related childhood literature is scarce, and EMLA is tried for the first time in fissure treatment. Methods: One hundred two children with anal fissures were allocated randomly into 4 groups. Placebo group (P; n = 20) received vaseline; group L (n = 24), 10% lidocaine; group EMLA (n = 25), eutectic mixture of 5% prilocaine-5% lidocaine; and group GTN (n = 22), 0.2% glyceryl trinitrate ointment twice daily to the distal anal canal. Symptoms and physical findings were separately scored as 0, 1, and 2. On the 10th day, the number of patients with scores of 0 (unresponsive) and in the 8th week with scores of 2 (healed and symptom free) were analyzed statistically. Results: Ninety-one patients completed the study. On the 10th day children with 0 symptomatic and fissure healing scores were, respectively, 90% to 95% in group P, 75% to 80% in group L, 20% to 40% in group EMLA, and 5% to 10% in group GTN. These results were statistically significant. In the eighth week, children with symptomatic and healing scores of 2 were, respectively, 10% to 5% in group P, 42% to 29% in group L, 76% to 64% in group EMLA, and 91% to 82% in group GTN. Results in groups GTN and EMLA were statistically similar (P >.05) and better than the other 2 groups (P <.05). Conclusion: Faster response rates could be achieved by GTN application, and similar and high success rates could be gained by GTN or EMLA by 8 weeks of treatment. J Pediatr Surg 37:1313-1316. Copyright 2002, Elsevier Science (USA). All rights reserved.