Pain, Retinopathy of Prematurity
Conditions
Keywords
Pain, Retinopathy of Prematurity, Neonates
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.
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.
Interventions
DRUGProparacaine Hydrochloride Ophthalmic Solution
1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PIPP Score | 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
| Measure | Time frame | Description |
|---|---|---|
| PIPP Score | within 5 minutes after Proparacaine administration | PIPP scores measure immediately after Proparacaine administration |
| Bradycardia/Desaturation | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment for this study was terminated due to poor enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Proparacaine Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops
Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops | 2 |
| Standard of Care Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops. | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated prior to completion | 2 | 3 |
Baseline characteristics
| Characteristic | Standard of Care | Proparacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 0.12 years STANDARD_DEVIATION 0.006 | 0.14 years STANDARD_DEVIATION 0.028 | 0.13 years STANDARD_DEVIATION 0.016 |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Change from baseline to time immediately following mydriatic drop administration
Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.
Secondary
Bradycardia/Desaturation
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
Time frame: Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected
Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.
Secondary
PIPP Score
PIPP scores measure immediately after Proparacaine administration
Time frame: within 5 minutes after Proparacaine administration
Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.
Secondary
PIPP Score
PIPP score measure immediately following mydriatic drop administration
Time frame: within 5 minutes after Mydriatic drop administration
Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.