Clinical Trial: Pain Response During Examination for Retinopathy of Prematurity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants

Brief Summary: Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.

Detailed Summary:
Sponsor: National Bioethics Commission of Brazil

Current Primary Outcome: Pain secondary to eye examination [ Time Frame: 2 minutes after the exam ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Bioethics Commission of Brazil

Dates:
Date Received: March 14, 2008
Date Started: March 2008
Date Completion:
Last Updated: July 21, 2010
Last Verified: September 2009