A blinded randomised placebo controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants

Research Services, University of Oxford0 sites31 target enrollmentJuly 29, 2015

Overview

Registry

who.int

Start Date

July 29, 2015

End Date

March 15, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Research Services, University of Oxford

•1\. Participants will be in\-patients on the neonatal unit at the John Radcliffe Hospital, Oxford
•2\. Infants born less than 32 weeks’ gestation or birth weight \<1501 g
•3\. At the time of study, infants will be between 34 and 42 weeks gestational age (GA) and will be studied if they require a clinical heel lance and retinopathy of prematurity (ROP) screening on the same test occasion. We will study infants during a single ROP examination when they are greater than or equal to 34 weeks’ gestation
•4\. Infants for whom parents/guardians have consented to inclusion in the trial.; Upper Age Limit 42 weeks
•Lower Age Limit 34 weeks
•5\. Senior clinician considers inclusion in trial to be medically appropriate (added 04/02/2016\)

•1\. Intraventricular haemorrhage \> grade II
•2\. Short bowel syndrome
•3\. Receiving nil by mouth due to documented gut pathology
•4\. Received opiates in the last 72 hours
•5\. Received other analgesics or sedatives in the last 24 hours
•6\. Previously documented episode of morphine sensitivity
•7\. Congenital malformation or genetic condition known to affect neurological development
•8\. Senior clinician considers inclusion in trial to be medically appropriate
•9\. Born to mothers who regularly use opiates during pregnancy or while breastfeeding or expressing breast milk