Pediatric Bowel Preparation: Sodium Picosulfate, Magnesium Oxide, Citric Acid Polyethylene Glycol, a Randomized Trial

Overview

Journal World J Gastroenterol

Publisher Baishideng Publishing Group

Specialty Gastroenterology

Date 2020 Nov 12

PMID 33177798

Citations 2

Authors

Carmen Cuffari

Steven L Ciciora

Masakazu Ando

Mena Boules

Joseph M Croffie

Affiliations

Soon will be listed here.

Abstract

Background: Bowel preparation in children can be challenging.

Aim: To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid (SPMC) bowel preparation in children.

Methods: Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ½ dose × 2, SPMC 1 dose × 2, or polyethylene glycol (PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders (rating of 'excellent' or 'good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations.

Results: 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ½ dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was 'very easy' or 'easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.

Conclusion: SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.

Citing Articles

The unmet needs for identifying the ideal bowel preparation.

Tontini G, Prada A, Sferrazza S, Ciprandi G, Vecchi M JGH Open. 2021; 5(10):1135-1141.

PMID: 34621998 PMC: 8485412. DOI: 10.1002/jgh3.12653.

Bowel Preparation for Pediatric Colonoscopy.

Mamula P, Nema N Front Pediatr. 2021; 9:705624.

PMID: 34540766 PMC: 8442953. DOI: 10.3389/fped.2021.705624.

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