Pain and distress outcomes in infants and children: a systematic review.

The aim of the present study was to systematically review the recent literature about pain and distress outcomes in children and critically analyze the methodological quality of the reports. The systematic review was based on the PRISMA statement and performed by selecting articles that are indexed in scientific databases. The methodological quality of reports was examined using STROBE statement, for observational studies, and CONSORT statement, for randomized controlled trials. The PedIMMPACT consensus was used to evaluate the psychometric quality of pain instruments. We analyzed 23 empirical studies, including 14 randomized controlled trials, seven cross-sectional studies, and two studies with cohort designs. Fourteen studies included preschool- and schoolchildren, and nine studies included infants. Regarding studies with infants, pain responses were evaluated by heart rate, crying and behavioral observation scales, and distress was evaluated only by salivary cortisol. Four-handed care and sensorial saturation interventions were used to evaluate efficacy to reduce pain and distress responses. Concerning studies with children, both pain and distress responses were evaluated by self- and hetero-reports, behavioral observation and/or physiological measures. Distraction was effective for reducing pain and distress during burn dressing changes and needle procedures, and healing touch intervention reduced distress and pain in chronic patients. All of the studies scored at least 60% in the methodological quality assessment. The pain outcomes included measures of validity that were classified as well-established by the PedIMMPACT. This systematic review gathers scientific evidence of distress-associated pain in children. Pain and distress were measured as distinct constructs, and their associations were poorly analyzed.