Does morphine provide effective pain relief during painful procedures performed in newborn babies as part of their essential medical care?
- Conditions
- Screening for Retinopathy of Prematurity is an essential yet painful routine test that is performed multiple times in infants who are born prematurely. Premature infants also regularly require heel lance for blood tests. We will conduct a randomised placebo-controlled trial to examine whether morphine is an effective analgesic for these procedures.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-003237-25-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 31
The study will be conducted in the neonatal unit at the John Radcliffe Hospital, Oxford.
Inclusion Criteria
•Participants will be in-patients on the neonatal unit at the John Radcliffe Hospital, Oxford.
•Infants born less than 32 weeks’ gestation or birth weight <1501 g
•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 test occasion when they are greater than or equal to 34 weeks’ gestation.
Infants for whom parents/guardians have given written informed consent for inclusion in the trial.
Parents/guardians have consented to inclusion in the trial.Senior clinician considers inclusion in trial to be medically appropriate.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria:
•intraventricular haemorrhage > grade II
•short bowel syndrome
•receiving nil by mouth due to documented gut pathology
•received opiates in the last 72 hours
•received other analgesics or sedatives in the last 24 hours
•previously documented episode of morphine sensitivity
•congenital malformation or genetic condition known to affect neurological development
•born to mothers who regularly use opiates during pregnancy or while breastfeeding or expressing breast milk.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method