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QUESTION: In children with constipation, what is the effectiveness of cisapride (a prokinetic agent)?
Design
12 week randomised (allocation concealed*), blinded {clinicians, patients, outcome assessors, and statisticians}†* placebo controlled trial.
Setting
Gastroenterology clinic of a hospital in Mexico City, Mexico.
Patients
40 children who were 2–16 years of age, had a history of chronic constipation, and had <3 bowel movements per week during a 2 week observation period before enrolment. Exclusion criteria were Hirschsprung disease, other congenital abnormalities of the gastrointestinal tract, or pelvic floor dyssynergia. Data were available for 36 patients (90%) (mean age 6 y, 67% boys).
Intervention
Patients were disimpacted and allocated to cisapride (n=17) or placebo (n=19) for 12 weeks. The medications were given as an oral suspension, 0.2 mg/kg of body weight per …
Footnotes
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Source of funding: In part, Janssen Pharmaceutics.
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For correspondence: Dr S Nurko, Pediatric Gastroenterology, Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.
↵† Information provided by author.