Clinical trial NCT01266824: Proparacaine and Mydriatic Eye Drops
Official title: Randomized Control Trial of the Effects of Proparacaine on the Pain Response to Mydriatic Eye Drops
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Retinopathy of Prematurity
Keywords: Pain
Retinopathy of Prematurity
Neonates
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PIPP Score
timeFrame: Change from baseline to time immediately following mydriatic drop administration
Secondary outcomes:
measure: PIPP Score
timeFrame: within 5 minutes after Proparacaine administration
measure: Bradycardia/Desaturation
timeFrame: Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected
measure: PIPP Score
timeFrame: within 5 minutes after Mydriatic drop administration
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital NICU
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Amy MP Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: