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

Dr. Sami Ulus Children's Hospital

Status: Unknown

Conditions: Retinopathy of Prematurity

Treatments: Drug: Topical anaesthetic drop with placebo; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01872871

B.10.4.İSM.4.06.68.49/231

B.10.4.İSM.4.06.68.49 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• congenital anomalies, necrotising enterocolitis, surgical problems

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

local anasthetic drops

Placebo Comparator group

Description:

topical anaesthetic drop with placebo

Treatment:

Drug: Topical anaesthetic drop with placebo

Paracetamol

Active Comparator group

Description:

Topical anaesthetic drop with Paracetamol

Treatment:

Drug: Paracetamol