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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872871

Enrollment

Registered

2013-06-07

Start date

2013-01-31

Completion date

2014-01-31

Last updated

2013-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

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.

Interventions

DRUGParacetamol

paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops

DRUGTopical anaesthetic drop with placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* congenital anomalies, necrotising enterocolitis, surgical problems

Design outcomes

Primary

Measure	Time frame
Reducing pain assessment score	2 weeks

Countries

Turkey (Türkiye)

Contacts

Primary ContactSerdar Beken

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026