Assessment of Abdominal Pain Through Global Outcomes and Recent FDA Recommendations in Children. Are We Ready for Change?

Abdominal pain endpoints currently recommended by the FDA and EMA for adult patients with irritable bowel syndrome may not be reliable in children

“…In a previous study, we analyzed how the results of a large RCT in children would be affected by the use of the FDA recommended pain endpoints if those would have been utilized in substitution of the previously accepted global outcomes (satisfactory relief and satisfaction with treatment). The study showed that the global outcomes were more comprehensive and better reflected the child's disability . The results of the study suggest that both endpoints may be measuring different concepts.…”

Express Immunochromatographic Detection of Rotavirus and Adenovirus Antigens in Pre-Hospital Differential Diagnosis of Acute Abdominal Pain in Children

“…Симптоматика у них нередко нарастает стремительно, ребенок становится беспокойным, отка-зывается от еды. Острая хирургическая патология при этом часто сопровождается повышением температуры до фебрильных цифр, многократной рвотой, разжиже-нием стула [8,11]. Маленький ребенок обычно негатив-но реагирует на осмотр, что затрудняет физикальное обследование.…”

Recommendations for pharmacological clinical trials in children with irritable bowel syndrome: the Rome foundation pediatric subcommittee on clinical trials

“…A large part of the treatment of IBS is to reduce disability in children. Pediatric studies conducted on children with FADPs have shown that pain improvement does not always correlate with improvements of disability . Children are frequently encouraged to attend school and participate in age appropriate activities no matter the level of pain.…”

“…The use of these co‐primary endpoints was subsequently also adopted by the European Medicines Agency (EMA) in 2013 . It remains unclear whether these recommendations are adequate for studies in children . Specific considerations in the pediatric population frequently preclude using the same methodology in adults and children.…”

“…18 It remains unclear whether these recommendations are adequate for studies in children. 19 Specific considerations in the pediatric population frequently preclude using the same methodology in adults and children. Developmental and cognitive limitations and differences in clinical relevance between adults and children make some adult endpoints poorly applicable to children.…”