Prospective, randomized, double-blind trial to validate the efficacy of an oral herbal gel on pain in the newborn during minor diagnostic-therapeutic procedures.

Background: Term and preterm infants are frequently exposed to painful procedures and stimuli during hospitalization in the Neonatal Intensive Care Unit (NICU). Pain is widely recognized to cause short- and long-term effects in the newborn. In recent years there has been a growing medical interest and a strong demand from parents for phytotherapeutic drugs, but literature data are limited, and excellent methodological studies are necessary to evaluate the importance of phytotherapy in the neonatal period.

Methods: We evaluated the use of an oral phytotherapeutic gel based on chamomile, angelica and oats in the management of full term and preterm infant pain caused by minor diagnostic or therapeutic procedures. We enrolled full term infants (>37 weeks gestational age [GA]) and preterm infants with higher GA than 28 weeks, weighing more than 1000 grams. Assessed painful procedures were minor diagnostic or therapeutic ones. Newborns were double-blind randomized into two groups (A and B) to orally receive the phytotherapeutic gel (solution A) and a gel of the same consistency and aroma (solution B) before the painful procedure.

Results: The group of newborns to whom solution A had been administered showed significantly lower scores in the Pain Scale (P<0.01) during painful procedure. This figure indicates that the herbal medicine has been effective in reducing pain experience in the population of examined newborns.

Conclusions: To the best of our literature research, our work is the first scientific study highlighting the possibility of preventive beneficial effects of phytotherapeutic drugs on pain control.