Pediatric Dosing for Scopolamine and Domperidone
Critical Limitation: Scopolamine Dosing Not Established in Provided Evidence
No pediatric dosing information for scopolamine was found in the available evidence. The evidence provided does not contain guidelines or research specifically addressing scopolamine use in children.
Domperidone Dosing in Pediatric Patients
For domperidone in children, the evidence-based dose is 0.25 mg/kg three times daily, though recent high-quality data shows this low dose is no more effective than placebo for acute gastroenteritis. 1
Evidence-Based Dosing Regimens
The literature provides conflicting dosing recommendations:
- Low-dose regimen (2019 Phase 3 trial): 0.25 mg/kg orally three times daily for 2-7 days 1
- Higher-dose regimen (2006 guideline): 0.2 mg/kg three times daily for infants, or 2 mg/kg/day divided four times daily for children 1 month to 12.7 years 2
Critical Safety Considerations
Domperidone carries significant cardiac risks in children, prompting regulatory safety warnings in 2014. 3
- The Korean Ministry of Food and Drug Safety issued warnings about adverse cardiac effects, specifically QT prolongation risk 3
- Following this warning, prescribing patterns shifted toward lower doses and shorter treatment durations (≤7 days) 3
- Maximum daily dosage should not exceed 30 mg 3
- Co-prescription with QT-prolonging medications should be avoided 3
Efficacy Evidence
The most recent and highest-quality evidence (2019 randomized, double-blind, phase 3 trial) demonstrates that low-dose domperidone is ineffective for pediatric nausea and vomiting. 1
- Only 32.0% of domperidone-treated patients had no vomiting episodes within 48 hours versus 33.8% with placebo (no significant difference) 1
- For nausea in children ≥4 years: 35.7% domperidone versus 38.6% placebo (no significant difference) 1
- The study was terminated early due to futility 1
Historical Context
Older uncontrolled studies from 2006 showed apparent benefit:
- 64.5% improvement in cough symptoms in infants at 0.2 mg/kg three times daily 2
- 100% improvement (p < 0.05) in children 1 month to 12.7 years at 2 mg/kg/day divided four times daily 2
However, these were unblinded, before-and-after intervention studies without placebo controls, making them substantially weaker evidence than the 2019 randomized controlled trial 2, 1
Clinical Recommendation
Given the lack of proven efficacy at safe doses and documented cardiac risks, domperidone should be used with extreme caution in pediatric patients, if at all. 1, 3 If prescribed despite these limitations, use 0.25 mg/kg three times daily for no more than 7 days, avoid doses exceeding 30 mg daily, and screen for cardiac risk factors and interacting medications. 1, 3