Registration and Treatment of Pain During Eye Examination of Prematurity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by St. Olavs Hospital
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01552993
First received: March 2, 2012
Last updated: June 7, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Infant, Premature
Retinopathy
Drug: paracetamol
Drug: sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Registration and Treatment of Pain During Eye Examination of Prematurity

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers


Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paracetamol
Paracetamol mixture 20 mg/kg + pacifier and sucrose
Drug: paracetamol
Paracetamol mixture 20 mg/kg + pacifier and glucose
Other Name: Paracetamol
Placebo Comparator: placebo
pacifier and sucrose only
Drug: sucrose
pacifier and sucrose

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.

  Eligibility

Ages Eligible for Study:   31 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with ongoing analgesic treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552993

Contacts
Contact: Hakon Bergseng, PhD +47 95088255 hakon.bergseng@stolav.no
Contact: Laila Kristoffersen laila.kristoffersen@stolav.no

Locations
Norway
St.Olavs University Hospital Recruiting
Trondheim, Trondelag, Norway, 7006
Contact: Hakon Bergseng       hakon.bergseng@stolav.no   
Principal Investigator: Håkon Bergseng, PhD         
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Hakon Bergseng, PhD St.Olavs University Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01552993     History of Changes
Other Study ID Numbers: HB2012-02
Study First Received: March 2, 2012
Last Updated: June 7, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
prematurity
retinopathy
pain
acetaminophen

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 18, 2014