Promoting tolerance of enteral feeds in children and young people: domperidone

Evidence strengths and limitations

Overall, there was very limited published evidence showing whether using domperidone off-label improves tolerance of enteral feeds through stimulating gastrointestinal motility in children and young people being enterally fed.

The single relevant study focused on a very specific patient group – very low birth weight, preterm neonates in intensive care – so its results are not likely to be applicable to children or young people of other ages or in other care settings. In addition, some of the reporting of the study was unclear, for example, when measurements of gastric emptying time were taken. The authors report that randomisation was performed by a person not involved in the care of the neonates using sealed envelopes but it did not say if the envelopes where opaque therefore it was unclear whether allocation to treatment was concealed.

The study was small (n=22), meaning its results may not be reliable and may differ from those in larger studies with more diverse populations. The treatment period used (48 hours) was short, meaning the study was unable to assess whether the effects of domperidone were temporary or whether they would be maintained over time. More importantly, the study was not large enough or long enough to give reliable safety information for short- or long-term off-label use of domperidone.

The strongest evidence on the safety of domperidone comes from the safety information contained in the summary of product characteristics of existing licensed domperidone formulations, supplemented by specific safety warnings and safety reviews by the Medicines and Healthcare products Regulatory Agency and European Medicines Agency respectively.

The study focused mainly on short-term gastric emptying and described (without providing figures) that vomiting did not differ between the 2 groups. It did not assess and report other patient-related outcomes of feeding tolerance, such as regurgitation, or clinically relevant outcomes such as nutrition absorption, growth or survival.