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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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ClinicalTrials.gov 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
Sponsor:
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

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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 ]


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01872871


Contacts
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Contact: Serdar Beken

Locations
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Turkey
Dr. Sami Ulus Childrens Hospital Recruiting
Ankara, Turkey, 06080
Contact: Serdar Beken, M.D    00903123056449    serbeken@gmail.com   
Principal Investigator: Serdar Beken, M.D         
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital

Publications:
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Responsible Party: Serdar Beken, M.D., Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01872871     History of Changes
Other Study ID Numbers: B.10.4.İSM.4.06.68.49/231
B.10.4.İSM.4.06.68.49 ( 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:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Anesthetics
Acetaminophen
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics