Proparacaine and Mydriatic Eye Drops

February 15, 2013 updated by: Amy M Cohen, Children's Hospital of Philadelphia

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in PIPP Score
Time Frame: Change from baseline to time immediately following mydriatic drop administration
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PIPP Score
Time Frame: within 5 minutes after Proparacaine administration
PIPP scores measure immediately after Proparacaine administration
within 5 minutes after Proparacaine administration
Bradycardia/Desaturation
Time Frame: Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected
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
Time Frame: within 5 minutes after Mydriatic drop administration
PIPP score measure immediately following mydriatic drop administration
within 5 minutes after Mydriatic drop administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy MP Cohen, MD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 812311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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