Pain Response During Examination for Retinopathy of Prematurity

National Bioethics Commission of Brazil100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Retinopathy of Prematurity

Interventions

suck 12.5% dextrose in water 5 minutes before the procedureBEHAVIORAL

Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP

Eligibility

Sex: ALLMin age: 5 WeeksMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: * all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age Exclusion Criteria: * the ones that died before 6 weeks old

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Pain secondary to eye examination

Time frame: 2 minutes after the exam

Data from ClinicalTrials.gov

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