Proparacaine and Mydriatic Eye Drops

NCT01266824 | Terminated Results DMC

• 1 other identifier: 812311
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Retinopathy of Prematurity

Keywords

Pain; Retinopathy of Prematurity; Neonates

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• PIPP Score

  within 5 minutes after Proparacaine administration

• Bradycardia/Desaturation

  Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected

• PIPP Score

  within 5 minutes after Mydriatic drop administration

Study Arms (2)

Proparacaine

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Infants in this arm will not receive Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) prior to mydriatic eye drops.

Interventions

Proparacaine Hydrochloride Ophthalmic Solution DRUG

1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops

Proparacaine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants admitted to the Pennsylvania Hospital NICU who require an ophthalmologic examination.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Pennsylvania Hospital NICU

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Enrollment for the randomized controlled study above was poor and the study was terminated without patient analysis. An observational study of the pain response to mydriatic eye drops without use of Proparacaine was completed in place of this trial.

Results Point of Contact

• Title: Dr. Amy Cohen
• Organization: Children's Hospital of Philadelphia

cohenam@email.chop.edu

215-590-1000

Study Officials

• Amy MP Cohen, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 24, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 19, 2013
• Results First Posted: March 19, 2013

Record last verified: 2013-02

Locations

US (1)