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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
History of Changes

December 21, 2010
February 15, 2013
December 2010
August 2011   (final data collection date for primary outcome measure)
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.
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
Complete list of historical versions of study NCT01266824 on ClinicalTrials.gov Archive Site
  • 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
  • PIPP score [ Time Frame: Immediately after Proparacaine and Mydriatic drop administration ] [ Designated as safety issue: No ]
    PIPP scores measure immediately after Proparacaine administration and immediately after mydriatic administration
  • Bradycardia/Desaturation [ Time Frame: From immediately 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 NICU protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Pain
  • Retinopathy of Prematurity
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
  • 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
    Intervention: Drug: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01266824
812311
Yes
Amy M Cohen, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Amy MP Cohen, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP