Registration and Treatment of Pain During Eye Examination of Prematurity

St. Olavs Hospital

Status: Terminated

Conditions: Retinopathy; Infant, Premature

Treatments: Drug: sucrose; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01552993

HB2012-02

Details and patient eligibility

About

The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.

Full description

Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.

This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.

Enrollment: 5 patients

Sex: All

Ages: 31 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants < 32 weeks of gestational age (< 31+6 weeks)

Exclusion criteria

• Infants with ongoing analgesic treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups, including a placebo group

paracetamol

Experimental group

Description:

Paracetamol mixture 20 mg/kg + pacifier and sucrose

Treatment:

Drug: paracetamol

placebo

Placebo Comparator group

Description:

pacifier and sucrose only

Treatment:

Drug: sucrose