The year-long study examined the effects of morphine as an analgesic for premature non-ventilated babies undergoing routine eye examinations. Thirty-one infants were enrolled in the trial, and assigned to either morphine or placebo treatment.
The results show that administration of oral morphine to non-ventilated premature infants prior to retinopathy of prematurity screening has the potential for harm without suggestion of analgesic efficacy. Difficulties in measuring infant pain are widely recognised, and the methodology used to measure both analgesic efficacy and side effects of a pharmacological intervention in the Poppi trial sets new standards for the conduct of clinical trials of analgesics in infants.