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Registration and Treatment of Pain During Eye Examination of Prematurity

Primary Purpose

Infant, Premature, Retinopathy

Status

Terminated

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

paracetamol

sucrose

About this trial

This is an interventional treatment trial for Infant, Premature focused on measuring prematurity, retinopathy, pain, acetaminophen

Eligibility Criteria

31 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Infants with ongoing analgesic treatment

Sites / Locations

St.Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

paracetamol

placebo

Arm Description

Paracetamol mixture 20 mg/kg + pacifier and sucrose

pacifier and sucrose only

Outcomes

Primary Outcome Measures

pain

Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers

Secondary Outcome Measures

Full Information

NCT ID

NCT01552993

First Posted

March 2, 2012

Last Updated

April 21, 2016

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT01552993

Brief Title

Registration and Treatment of Pain During Eye Examination of Prematurity

Official Title

Registration and Treatment of Pain During Eye Examination of Prematurity

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

the chosen intervention was obviously ineffective

Study Start Date

March 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Premature, Retinopathy

Keywords

prematurity, retinopathy, pain, acetaminophen

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

paracetamol

Arm Type

Experimental

Arm Description

Paracetamol mixture 20 mg/kg + pacifier and sucrose

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

pacifier and sucrose only

Intervention Type

Drug

Intervention Name(s)

paracetamol

Intervention Description

Paracetamol mixture 20 mg/kg + pacifier and glucose

Intervention Type

Drug

Intervention Name(s)

sucrose

Intervention Description

pacifier and sucrose

Primary Outcome Measure Information:

Title

pain

Description

Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

31 Weeks

Maximum Age & Unit of Time

37 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants < 32 weeks of gestational age (< 31+6 weeks) Exclusion Criteria: Infants with ongoing analgesic treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hakon Bergseng, PhD

Organizational Affiliation

St.Olavs University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St.Olavs University Hospital

City

Trondheim

State/Province

Trondelag

ZIP/Postal Code

7006

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

Registration and Treatment of Pain During Eye Examination of Prematurity

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