Nineteen clinical trials were included in the review (n=782). There were six trials of omeprazole (n=151), six of lansoprazole (n=282), four of esomeprazole (n=257), two of pantoprazole (n=68) and one of rabeprazole (n=24).
Off-label use of omeprazole, lansoprazole and esomeprazole in children was found to be highly appropriate given the consistency between pharmacokinetics, efficacy and safety. Moderate appropriateness was attributed to pantoprazole due to a lack of pharmacokinetic data and insufficient efficacy trials. No adequate evidence was found for rabeprazole and so its off-label use was not considered to be appropriate in children. All compounds gave rise to a safety profile in children that was comparable to adults. However, in omeprazole adverse events of the respiratory system were reported more frequently in children aged up to two years of age.