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Proparacaine and Mydriatic Eye Drops

This study has been terminated.
(Recruitment for the study has been terminated due to poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Amy M Cohen, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01266824
First received: December 21, 2010
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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 Intervention
Pain
Retinopathy of Prematurity
Drug: Proparacaine Hydrochloride Ophthalmic Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Control Trial of the Effects of Proparacaine on the Pain Response to Mydriatic Eye Drops

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Change in PIPP Score [ Time Frame: Change from baseline to time immediately following mydriatic drop administration ] [ Designated as safety issue: No ]
    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:
  • PIPP Score [ Time Frame: within 5 minutes after Proparacaine administration ] [ Designated as safety issue: No ]
    PIPP scores measure immediately after Proparacaine administration

  • Bradycardia/Desaturation [ Time Frame: Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected ] [ Designated as safety issue: No ]
    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

  • PIPP Score [ Time Frame: within 5 minutes after Mydriatic drop administration ] [ Designated as safety issue: No ]
    PIPP score measure immediately following mydriatic drop administration


Enrollment: 5
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Proparacaine Hydrochloride Ophthalmic Solution
No Intervention: Standard of Care
Infants in this arm will not receive Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) prior to mydriatic eye drops.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266824

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

No publications provided

Responsible Party: Amy M Cohen, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01266824     History of Changes
Other Study ID Numbers: 812311
Study First Received: December 21, 2010
Results First Received: December 10, 2012
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Pain
Retinopathy of Prematurity
Neonates

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Mydriatics
Ophthalmic Solutions
Pharmaceutical Solutions
Propoxycaine
Proxymetacaine
Tetrahydrozoline
Anesthetics
Anesthetics, Local
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Nasal Decongestants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014