COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01872871
Recruitment Status : Unknown
Verified June 2013 by Serdar Beken, Dr. Sami Ulus Children's Hospital.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Information provided by (Responsible Party):
Serdar Beken, Dr. Sami Ulus Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Paracetamol Drug: Topical anaesthetic drop with placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : January 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: local anasthetic drops
topical anaesthetic drop with placebo
Drug: Topical anaesthetic drop with placebo
Active Comparator: Paracetamol
Topical anaesthetic drop with Paracetamol
Drug: Paracetamol
paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops

Primary Outcome Measures :
  1. Reducing pain assessment score [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • congenital anomalies, necrotising enterocolitis, surgical problems

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 identifier (NCT number): NCT01872871

Layout table for location contacts
Contact: Serdar Beken

Layout table for location information
Dr. Sami Ulus Childrens Hospital Recruiting
Ankara, Turkey, 06080
Contact: Serdar Beken, M.D    00903123056449   
Principal Investigator: Serdar Beken, M.D         
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital

Layout table for additonal information
Responsible Party: Serdar Beken, M.D., Dr. Sami Ulus Children's Hospital Identifier: NCT01872871    
Other Study ID Numbers: B.10.4.İSM.
B.10.4.İSM. ( Registry Identifier: Sami Ulus )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants