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.
Completing the Poppi trial has been a fantastic achievement. The project has bought together people from many disciplines who want to improve the treatment of pain in prematurely-born infants. We are very excited about the next phase of our work where we will use the methodology developed in the Poppi trial to test the analgesic efficacy and safety of other pharmacological interventions.
- said Professor Rebeccah Slater, head of Paediatric Neuroimaging.
For an overview of the procedure and results of the study, watch our animation:
or read an overview on the NPEU website.
The journal article can be found here: Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial
and you can read our comment in Lancet Child and Adolescent here: A universal right to pain relief: balancing the risks in a vulnerable patient population.