Pain Response During Examination for Retinopathy of Prematurity (ROP)

National Bioethics Commission of Brazil

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Behavioral: suck 12.5% dextrose in water 5 minutes before the procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00648687

HCPA 07437

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 weeks to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

I

Experimental group

Description:

this group will receive oral water and glucose prior to eye exam

Treatment:

Behavioral: suck 12.5% dextrose in water 5 minutes before the procedure

II

No Intervention group

Description:

this group is the control group.