Proparacaine and Mydriatic Eye Drops

Pain Clinical Trial

Official title:

Randomized Control Trial of the Effects of Proparacaine on the Pain Response to Mydriatic Eye Drops

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01266824
• Other study ID #: 812311
• Status: Terminated
• Phase: N/A
• First received: December 21, 2010
• Last updated: February 15, 2013
• Start date: December 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Proparacaine Hydrochloride Ophthalmic Solution
1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops

Locations

Country	Name	City	State
United States	Pennsylvania Hospital NICU	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PIPP Score	PIPP scores measure immediately after Proparacaine administration	within 5 minutes after Proparacaine administration	No
Secondary	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	No
Secondary	PIPP Score	PIPP score measure immediately following mydriatic drop administration	within 5 minutes after Mydriatic drop administration	No