Registration and Treatment of Pain During Eye Examination of Prematurity

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01552993

Enrollment

Registered

2012-03-13

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2016-04-22

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

Conditions

Infant, Premature, Retinopathy

Keywords

prematurity, retinopathy, pain, acetaminophen

Brief summary

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

Detailed 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.

Interventions

DRUGparacetamol

Paracetamol mixture 20 mg/kg + pacifier and glucose

DRUGsucrose

pacifier and sucrose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

31 Weeks to 37 Weeks

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Infants with ongoing analgesic treatment

Design outcomes

Primary

Measure	Time frame	Description
pain	5 minutes	Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers

Countries

Norway

Outcome results

None listed

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