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Proparacaine and Mydriatic Eye Drops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01266824
Recruitment Status : Terminated (Recruitment for the study has been terminated due to poor enrollment)
First Posted : December 24, 2010
Results First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):
Amy M Cohen, Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Pain Retinopathy of Prematurity Drug: Proparacaine Hydrochloride Ophthalmic Solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Control Trial of the Effects of Proparacaine on the Pain Response to Mydriatic Eye Drops
Study Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. PIPP Score [ Time Frame: within 5 minutes after Proparacaine administration ]
    PIPP scores measure immediately after Proparacaine administration

  2. 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

  3. PIPP Score [ Time Frame: within 5 minutes after Mydriatic drop administration ]
    PIPP score measure immediately following mydriatic drop administration

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01266824

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United States, Pennsylvania
Pennsylvania Hospital NICU
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: Amy MP Cohen, MD Children's Hospital of Philadelphia

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Responsible Party: Amy M Cohen, MD, Children's Hospital of Philadelphia Identifier: NCT01266824     History of Changes
Other Study ID Numbers: 812311
First Posted: December 24, 2010    Key Record Dates
Results First Posted: March 19, 2013
Last Update Posted: March 19, 2013
Last Verified: February 2013

Keywords provided by Amy M Cohen, Children's Hospital of Philadelphia:
Retinopathy of Prematurity

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents