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The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

Primary Purpose

Retinopathy of Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Topical anaesthetic drop with placebo
Sponsored by
Dr. Sami Ulus Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinopathy of Prematurity

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational age below 32 weeks or birth weight below 1500 grams

Exclusion Criteria:

  • congenital anomalies, necrotising enterocolitis, surgical problems

Sites / Locations

  • Dr. Sami Ulus Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

local anasthetic drops

Paracetamol

Arm Description

topical anaesthetic drop with placebo

Topical anaesthetic drop with Paracetamol

Outcomes

Primary Outcome Measures

Reducing pain assessment score

Secondary Outcome Measures

Full Information

First Posted
June 4, 2013
Last Updated
June 6, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01872871
Brief Title
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local anasthetic drops
Arm Type
Placebo Comparator
Arm Description
topical anaesthetic drop with placebo
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
Topical anaesthetic drop with Paracetamol
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops
Intervention Type
Drug
Intervention Name(s)
Topical anaesthetic drop with placebo
Primary Outcome Measure Information:
Title
Reducing pain assessment score
Time Frame
2 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational age below 32 weeks or birth weight below 1500 grams Exclusion Criteria: congenital anomalies, necrotising enterocolitis, surgical problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Beken
Facility Information:
Facility Name
Dr. Sami Ulus Childrens Hospital
City
Ankara
ZIP/Postal Code
06080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Beken, M.D
Phone
00903123056449
Email
serbeken@gmail.com
First Name & Middle Initial & Last Name & Degree
Serdar Beken, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
12682806
Citation
Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. doi: 10.1007/s00228-003-0585-3. Epub 2003 Apr 4.
Results Reference
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The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

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