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Registration and Treatment of Pain During Eye Examination of Prematurity

This study has been terminated.
(the chosen intervention was obviously ineffective)
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital Identifier:
First received: March 2, 2012
Last updated: April 21, 2016
Last verified: April 2016
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
Drug: paracetamol
Drug: sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, 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 ]
    Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers

Enrollment: 5
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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
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.


Ages Eligible for Study:   31 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with ongoing analgesic treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01552993

St.Olavs University Hospital
Trondheim, Trondelag, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Principal Investigator: Hakon Bergseng, PhD St.Olavs University Hospital
  More Information

Responsible Party: St. Olavs Hospital Identifier: NCT01552993     History of Changes
Other Study ID Numbers: HB2012-02
Study First Received: March 2, 2012
Last Updated: April 21, 2016

Keywords provided by St. Olavs Hospital:

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics processed this record on April 26, 2017