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

Research Services, University of Oxford0 个研究点目标入组 31 人开始时间: 2015年7月29日最近更新: 2023年8月28日

试验速览

•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

发起方

Research Services, University of Oxford