Proparacaine and Mydriatic Eye Drops

Randomized Control Trial of the Effects of Proparacaine on the Pain Response to 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.

Study Overview

• Status: Terminated
• Conditions: Pain; Retinopathy of Prematurity
• Intervention / Treatment: Drug: Proparacaine Hydrochloride Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital NICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proparacaine; Infants in this group will receive 1 drop of Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops	Drug: Proparacaine Hydrochloride Ophthalmic Solution; 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops
No Intervention: Standard of Care; Infants in this arm will not receive Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) prior to mydriatic eye drops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PIPP Score	Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score >7 typically indicates a pain response while a score >12 indicates more severe pain.	Change from baseline to time immediately following mydriatic drop administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIPP Score	PIPP scores measure immediately after Proparacaine administration	within 5 minutes after Proparacaine administration
Bradycardia/Desaturation	Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops	Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected
PIPP Score	PIPP score measure immediately following mydriatic drop administration	within 5 minutes after Mydriatic drop administration

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Amy MP Cohen, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: February 15, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Retinopathy of Prematurity; Neonates
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Proxymetacaine; Ophthalmic Solutions
• Other Study ID Numbers: 812311