What question did this study set out to answer?

To determine whether cisapride treatment induces QTc interval prolongation or cardiac electrical abnormalities in pediatric patients with gastroesophageal reflux.

April 1, 2001Journal of Pediatric Gastroenterology and Nutrition

Does Cisapride Influence Cardiac Rhythm? Results of a United States Multicenter, Double-Blind, Placebo-Controlled Pediatric Study

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Why the study?

Does cisapride prolong the QTc interval in children with gastroesophageal reflux?

Population

49 children between 6 months and 4 years of age with symptoms of gastroesophageal reflux not responding to…

Comparison

Cisapride 0.2 mg/kg three times daily for 3 to 8… vs Placebo

Design

RCT, Randomized, Double-blind

Follow-up

3 to 8 weeks

Authors

JLJoseph LevyJohns Hopkins University JKJeffrey A. KernNational Jewish Health AFAlex F. C. FloresUniversidade Federal do Rio Grande

Discussion

Member takes

Implication

Supports cisapride use in children with GERD without cardiac disease; confirms no QTc prolongation versus placebo in this RCT.

Key Points

To determine whether cisapride treatment induces QTc interval prolongation or cardiac electrical abnormalities in pediatric patients with gastroesophageal reflux.
Conducted a multicenter, double-blind, placebo-controlled trial in 49 children aged 6 months to 4 years with medical therapy-resistant gastroesophageal reflux.
Randomized participants to receive cisapride (0.2 mg/kg three times daily) or placebo for 3 to 8 weeks.
Blinded and independent review of baseline and post-treatment electrocardiograms (ECGs) was performed by two pediatric cardiologists to assess QTc changes.
Mean QTc among patients treated with cisapride was 408 ± 18 ms, with no values exceeding 450 ms.
The change from baseline QTc following 3 to 8 weeks of cisapride therapy was 2 ± 20 ms.
Cisapride produced no significant effect on cardiac electrical function compared with placebo in children without baseline cardiac disease or electrolyte abnormalities.

Structured PICO

Does cisapride prolong the QTc interval in children with gastroesophageal reflux?

Population

49 children between 6 months and 4 years of age with symptoms of gastroesophageal reflux not responding to medical therapy for at least 6 weeks, without underlying cardiac disease or electrolyte imbalance.

Intervention

Cisapride 0.2 mg/kg three times daily for 3 to 8 weeks

Comparator

Placebo

Outcome

QTc interval and change in QTc from baseline values after 3 to 8 weeks of treatmentsurrogate

In a pediatric population without underlying cardiac disease, cisapride did not significantly prolong the QTc interval compared to placebo.

Cite This Study

Levy et al. (2001) studied this question.

synapsesocial.com/papers/6a882b22aadaab60564fcb87 https://doi.org/10.1097/00005176-200104000-00013

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Does Cisapride Influence Cardiac Rhythm? Results of a United States Multicenter, Double-Blind, Placebo-Controlled Pediatric Study

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Does Cisapride Influence Cardiac Rhythm? Results of a United States Multicenter, Double-Blind, Placebo-Controlled Pediatric Study

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider