Background
Preterm infants are vulnerable and sensitive to stimuli, during their stay in neonatal intensive care they undergo frequent stressful and painful procedures. One of these painful procedures is the screening for retinopathy of prematurity, ROP. In Sweden all preterm infants born before gestation week 30 undergo ROP-screening. The screening involves regular eye examinations to detect ROP at the early stages and these examinations are both stressful and painful. Several studies have investigated different ways of pain management during eye examinations with inconsequent results. No study has investigated Clonidine as pain management during ROP-screening.
Aim
The aim of this clinical trial is to investigate the analgesic effect of clonidine during ROP eyeexaminations.
Method
This study is a multicenter randomized controlled clinical trial with a crossover design. Infants born before gestation week 30 and therefore undergoing ROP-screening, will be eligible for inclusion in the study. Infants will be recruited from two Swedish NICUs (neonatal intensive care units). The NICUs use different examination techniques, where NICU A uses indirect ophthalmoscopy while NICU B uses RetCam. A total of 50 infants will be recruited (25 at each NICU). During the first eye examination the infant will be randomized to either clonidine 4mcg/kg or sterile water in the equivalent dose 60 minutes before the eye examination. The order of the treatment is blinded for everyone except the nurse preparing the study solution. During the second eye examination the infant will receive the study solution, (intervention or placebo) that he/she did not receive the first time. The primary outcome of the study is pain assessment with the Premature Infant Pain Profile – Revised. The infants´ face and monitor showing oxygen saturation and heart rate will be videorecorded to be able to assess the pain afterwards. The secondary outcome is Galvanic Skin Response where three probes are attached to the infant’s foot sole to register changes in the sweat gland activity in response to stimuli such as pain or stress. The ophthalmologist performing the eye examination will also rate how easy it was to examine the infant by marking an X on a 10cm VAS scale with “very easy to examine” on one end and “very difficult to examine” on the other end. Data collection is ongoing with 19 infants included at the moment.