Registration and Treatment of Pain During Eye Examination of Prematurity

NCT ID: NCT01552993

Last Updated: 2016-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant, Premature Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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paracetamol

Paracetamol mixture 20 mg/kg + pacifier and sucrose

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Paracetamol mixture 20 mg/kg + pacifier and glucose

placebo

pacifier and sucrose only

Group Type PLACEBO_COMPARATOR

sucrose

Intervention Type DRUG

pacifier and sucrose

Interventions

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paracetamol

Paracetamol mixture 20 mg/kg + pacifier and glucose

Intervention Type DRUG

sucrose

pacifier and sucrose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Infants with ongoing analgesic treatment
Minimum Eligible Age

31 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hakon Bergseng, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs University Hospital

Locations

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St.Olavs University Hospital

Trondheim, Trøndelag, Norway

Site Status

Countries

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Norway

Other Identifiers

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HB2012-02

Identifier Type: -

Identifier Source: org_study_id

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