Registration and Treatment of Pain During Eye Examination of Prematurity

Not Applicable

Terminated

• Conditions: Infant, Premature; Retinopathy
• Interventions: Drug: sucrose; Drug: paracetamol

• Registration Number: NCT01552993
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

• Infants with ongoing analgesic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	sucrose	pacifier and sucrose only
paracetamol	paracetamol	Paracetamol mixture 20 mg/kg + pacifier and sucrose

Primary Outcome Measures

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

Trial Locations

Locations (1)

St.Olavs University Hospital; 🇳🇴 Trondheim, Trondelag, Norway