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

Not Applicable

• Conditions: Retinopathy of Prematurity
• Interventions: Drug: Topical anaesthetic drop with placebo; Drug: Paracetamol

• Registration Number: NCT01872871
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-06
• Last Update Submitted: 2013-06-06
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2013-08
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• congenital anomalies, necrotising enterocolitis, surgical problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
local anasthetic drops	Topical anaesthetic drop with placebo	topical anaesthetic drop with placebo
Paracetamol	Paracetamol	Topical anaesthetic drop with Paracetamol

Primary Outcome Measures

Name	Time	Method
Reducing pain assessment score	2 weeks

Trial Locations

Locations (1)

Dr. Sami Ulus Childrens Hospital; 🇹🇷 Ankara, Turkey