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Published on: August 1, 2019
Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol, a randomized
Carmen Cuffari1, Steven L Ciciora2, Masakazu Ando3
1Department of Pediatrics, The Johns Hopkins School of Medicine, Baltimore, MD 21287, United States. ccuffari@jhmi.edu.
Insights
Sodium picosulfate, magnesium oxide, and citric acid (SPMC) is an effective and safe bowel preparation for children aged 9-16. This new option demonstrated higher tolerability compared to polyethylene glycol (PEG).
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Research
- Pharmacology
Background:
- Bowel preparation in pediatric patients presents unique challenges.
- Effective and safe methods are crucial for successful colonoscopy in children.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid (SPMC) for bowel preparation in children aged 9-16 years.
- To compare SPMC with polyethylene glycol (PEG)-based preparations.
Main Methods:
- A phase 3, randomized, assessor-blinded, multicenter study involving 78 children aged 9-16.
- Participants were randomized to receive different doses of SPMC or PEG.
- Bowel preparation quality was assessed using the modified Aronchick Scale; tolerability and satisfaction were measured via questionnaire.
Main Results:
- SPMC demonstrated comparable efficacy to PEG in achieving adequate bowel preparation across age groups.
- Participants receiving SPMC (1 dose x 2) reported significantly higher ease of drinking compared to PEG.
- Treatment-emergent adverse events were less frequent with SPMC compared to PEG.
Conclusions:
- SPMC is an efficacious and safe bowel preparation option for pediatric patients undergoing colonoscopy.
- SPMC offers improved tolerability over PEG, enhancing patient experience.
- This study supports SPMC as a viable alternative for pediatric bowel preparation.
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.
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