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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552993
First Posted: March 13, 2012
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552993


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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01552993     History of Changes
Other Study ID Numbers: HB2012-02
First Submitted: March 2, 2012
First Posted: March 13, 2012
Last Update Posted: April 22, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics