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Use of Sucrose to Relieve Pain During Eye Exams in Infants

Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00161694
Enrollment
300
Registered
2005-09-12
Start date
2005-07-31
Completion date
Unknown
Last updated
2008-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity, Retinopathy of Prematurity, Pain

Keywords

pain control

Brief summary

The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.

Interventions

DIETARY_SUPPLEMENTsucrose solution

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
5 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

* All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen.

Exclusion criteria

* Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus. * Any infant being maintained on narcotics for any reason will not be eligible for the study. * All infants with major congenital anomalies will be excluded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026