Registration and Treatment of Pain During Eye Examination of Prematurity

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01552993
• Collaborator: Norwegian University of Science and Technology (Other)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature; Retinopathy	Drug: paracetamol; Drug: sucrose	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• 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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. pain [5 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 31 Weeks to 37 Weeks
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT01552993
• Other Study ID Numbers: HB2012-02
• First Posted: Mar 13, 2012
• Last Update Posted: Apr 22, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by St. Olavs Hospital: prematurity; retinopathy; pain; acetaminophen
• Additional relevant MeSH terms: Retinal Diseases; Premature Birth; Acetaminophen

Study Results

No Results Posted as of Apr 22, 2016