Registration and Treatment of Pain During Eye Examination of Prematurity

Infant, Premature Clinical Trial

Official title:

Registration and Treatment of Pain During Eye Examination of Prematurity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01552993
• Other study ID #: HB2012-02
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2012
• Last updated: February 2, 2016
• Start date: March 2012
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: St. Olavs Hospital
• Contact: Hakon Bergseng, PhD
• Phone: +47 95088255
• Email: hakon.bergseng[@]stolav.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Infants with ongoing analgesic treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth
• Retinal Diseases
• Retinopathy

Intervention

Drug:
• paracetamol
Paracetamol mixture 20 mg/kg + pacifier and glucose
• sucrose
pacifier and sucrose

Locations

Country	Name	City	State
Norway	St.Olavs University Hospital	Trondheim	Trondelag

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers	5 minutes	No