Cisapride for the treatment of constipation in children: A double-blind study

Objective: To determine whether cisapride is effective in the treatment of children with constipation. Study design: Double-blind placebo-controlled study in which children with chronic constipation were randomly assigned to treatment with cisapride or placebo for 12 weeks. Results: Forty children were enrolled, and 36 completed the therapy. Treatm ent successes occurred in 13 of 17 (76%) subjects in the cisapride group an d 8 of 19 (37%) subjects in the placebo group (P < .03). The odds ratio for response after cisapride administration was 8.2 times higher (95% CI 1.3 t o 49.4). During cisapride therapy, there was a significant improvement in n umber of spontaneous bowel movements per week (from 0.9 +/- 0.1 to 4.1 +/- 1.1), and there was a significant decrease in number of fecal soiling episo des per day (1.8 +/- 0.5 to 0.08 +/- 0.4), percent with encopresis (82% vs 23%), number of laxative doses per week (from 10.3 +/- 2.6 to 0.8 +/- 0.6), percent using laxatives (77% to 24%), and total gastrointestinal transit t ime (from 115.0 +/- 3.7 hours to 77.0 +/- 11.1 hours). With placebo, there were no significant changes in the number of spontaneous bowel movements (f rom 1.0 +/- 0.8 to 2.2 +/- 0.6), percent with encopresis (74% vs 47%), or t otal gastrointestinal transit time (from 112.5 +/- 4.9 hours to 95.4 +/- 9. 8 hours); but there was a significant decrease in number of fecal soiling e pisodes per day (from 1.3 +/- 0.4 to 0.4 +/- 0.2) and number of laxative do ses used per week (from 11.5 +/- 2.9 to 2.05 +/- 0.7). The final number of spontaneous bowel movements, fecal soiling episodes, laxatives used, or per cent patients with encopresis was not different when patients receiving cis apride were compared with those receiving placebo. Conclusion: Cisapride was effective in the treatment of children with const ipation. (J Pediatr 2000;136:35-40).