Proparacaine and Mydriatic Eye Drops
Proparacaine and Mydriatic Eye Drops
In this study, we will be evaluating whether premedication with an anesthetic eye drops leads
 to a decreased sensation of pain when given dilating eye drops prior to eye examinations to
 evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants.
A. Randomization of subjects: Infants will be randomized to receive Proparacaine versus no
 intervention based on computerized randomization performed by our statistician. Due to the
 lack of a placebo group, practitioners present at the time of examination will not able to be
 blinded to group assignment. Each infant will only be enrolled for one examination.

 B. Monitor setup/application: The Central Nervous System (CNS) Neonatal Neurological Monitor
 (Moberg Research) will be used to videotape each patient encounter and record vital sign
 information during the study period. The CNS monitor will record physiologic variables
 indirectly via cables attached to the bedside monitor. Before scheduled eye drop
 administration takes place, the appropriate connections between the bedside monitor and CNS
 monitor will be made in order to continuously record heart rate, respiratory rate, pulse
 oximetry, and blood pressure. A video camera attached to the CNS monitor will also be
 positioned to capture the subjects' facial activity and gross body movements. The monitor
 will be set up with enough time prior to eye drop administration such that baseline data can
 be collected before any intervention is performed. In addition, a video recording of the
 method of eyedrop administration will be assessed. The monitor will remain in place up to 5
 minutes after completion of eye drop administration.

 C. Eye drop administration: The CNS Monitor will be in place at least 3 minutes prior to
 administration of any eye drops to record baseline data on the infant. One drop of
 Proparacaine anesthetic ophthalmic solution will be applied to each eye of infants randomized
 to receive Proparacaine prior to the mydriatic eye drops. At least 30 seconds and no longer
 than 5 minutes after administration of Proparacaine, the mydriatic eye drops will be given as
 per routine standard practice for ophthalmologic examinations in the NICU.
Inclusion Criteria:

 -  Infants admitted to the Pennsylvania Hospital NICU who require an ophthalmologic
 examination.

 Exclusion Criteria:

 -  Infants with congenital anomalies, seizures, or other neurologic conditions or
 malformations that may alter the pain response

 -  Infants with corneal abrasions, corneal ulcers or other relative or absolute
 contraindications to proparacaine administration