Cohen, R.O'Loughlin, E.Davidson, G.Moore, D.Lawrence, D.2006-06-232006-06-231999Journal of Pediatrics, 1999; 134(3):287-2920022-34761097-6833http://hdl.handle.net/2440/7618<h4>Objective</h4>To evaluate the efficacy of cisapride in the treatment of uncomplicated gastroesophageal reflux in children younger than 36 months of age.<h4>Study design</h4>A total of 95 patients satisfied the entry criteria and were randomly assigned to double-blind treatment with either cisapride (n = 50), 0.2 mg/kg 4 times daily, or placebo (n = 45) for 2 weeks. At the end of the 2-week treatment period, symptom diary and parental evaluation with repeat 24-hour pH study were performed.<h4>Results</h4>Sixty-eight patients completed the trial (38 in the cisapride group and 30 in the placebo group). There were no significant differences in the symptoms of crying, vomiting, or gagging; the overall symptom intensity score; or parental global evaluations. There was a significant difference (P <.03) in the percent time pH <4, the number of reflux episodes lasting more than 5 minutes, and the duration of the longest episode. No significant difference was demonstrated for the number of episodes with pH <4 or the reflux score.<h4>Conclusions</h4>Cisapride was no better than placebo for relief of symptoms in children with uncomplicated gastroesophageal reflux. A beneficial effect was demonstrated in the cisapride group in relation to the measured parameters for esophageal acid exposure time.enEsophagusHumansGastroesophageal RefluxCisaprideGastrointestinal AgentsPlacebosTreatment FailureAdministration, OralChi-Square DistributionStatistics, NonparametricDouble-Blind MethodHydrogen-Ion ConcentrationInfantAustraliaFemaleMaleJournal article0030005475001999033710.1016/S0022-3476(99)70451-80000789858000092-s2.0-003350014569481