- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872871
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
June 6, 2013 updated by: Serdar Beken, Dr. Sami Ulus Children's Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Serdar Beken
Study Locations
-
-
-
Ankara, Turkey, 06080
- Recruiting
- Dr. Sami Ulus Childrens Hospital
-
Contact:
- Serdar Beken, M.D
- Phone Number: 00903123056449
- Email: serbeken@gmail.com
-
Principal Investigator:
- Serdar Beken, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- gestational age below 32 weeks or birth weight below 1500 grams
Exclusion Criteria:
- congenital anomalies, necrotising enterocolitis, surgical problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: local anasthetic drops
topical anaesthetic drop with placebo
|
|
Active Comparator: Paracetamol
Topical anaesthetic drop with Paracetamol
|
paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reducing pain assessment score
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
June 4, 2013
First Submitted That Met QC Criteria
June 6, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Estimate)
June 7, 2013
Last Update Submitted That Met QC Criteria
June 6, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Retinal Diseases
- Premature Birth
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Anesthetics
- Acetaminophen
- Anesthetics, Local
Other Study ID Numbers
- B.10.4.İSM.4.06.68.49/231
- B.10.4.İSM.4.06.68.49 (Other Identifier: Ethics Committe)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinopathy of Prematurity
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NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsTerminatedRetinopathy of Prematurity (ROP)United States
-
BayerRegeneron PharmaceuticalsCompletedAflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy (FIREFLEYE)Retinopathy of Prematurity (ROP)Spain, Singapore, Hong Kong, Korea, Republic of, Malaysia, Japan, Taiwan, Sweden, Portugal, Belgium, Argentina, Bulgaria, Italy, Austria, Brazil, Czechia, Greece, Hungary, Israel, Netherlands, Poland, Romania, Russian Federation, Slov... and more
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University Hospital FreiburgCompletedRetinopathy of Prematurity (ROP)Germany
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Novartis PharmaceuticalsCompletedRetinopathy of Prematurity (ROP)United States, Austria, Belgium, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Romania, Russian Federation, Saudi Arabia, Slovakia, Taiwan, Turkey, United Kingdom, Lithuania, Estonia
-
ShireCompletedRetinopathy of Prematurity (ROP)United States, Italy, Netherlands, Poland, Sweden, United Kingdom
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Zagazig UniversityCairo UniversityRecruitingRetinopathy of Prematurity Both EyesEgypt
-
ShireCompletedRetinopathy of Prematurity (ROP)United States, Italy, Netherlands, United Kingdom, Sweden, Poland
-
University Hospital FreiburgWithdrawn
-
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Georgetown UniversityCompleted
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Amazentis SAproDERM GmbHCompleted
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Amazentis SAproDERM GmbHCompletedErythema | Skin Inflammation | Sun Damaged SkinGermany
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Cairo UniversityUnknownLocal Anesthesia | SatisfactionSaudi Arabia
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Al-Azhar UniversityUnknownSkin Diseases | Breast Cancer | Skin CancerEgypt, Saudi Arabia
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Portsmouth Hospitals NHS TrustCompletedEpiretinal Membrane | Pseudophakic Cystoid Macular OedemaUnited Kingdom
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Maastricht University Medical CenterAlcon ResearchCompleted
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pH PharmaCompletedHealthy VolunteerKorea, Republic of
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