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Pain Management During Screening for Retinopathy of Prematurity

NCT04767178 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2021-02-23

No results posted yet for this study

Summary

Abstract Background: Screening examinations for retinopathy of prematurity (ROP) is critical to reduce ROP-related vision loss, however, the procedure is painful and uncomfortable, and topical anesthetics do not completely suppress the painful responses. The number of safe and effective pharmacological options to reduce pain during eye examinations for ROP screening in preterm infants is limited.

Objective: This study compared the efficacy of oral ibuprofen and oral paracetamol in reducing pain during screening for ROP in preterm infants.

Design: This prospective observational study was conducted at a tertiary-care neonatal intensive care units. Forty-four preterm infants with gestational age ≤ 32 weeks undergoing ROP screening were included. Each enrolled infant received either oral ibuprofen 10 mg/kg (n = 22) or oral paracetamol 10 mg/kg (n = 22) one hour before eye examination. The primary outcome measure was pain assessed by the Neonatal Pain, Agitation, and Sedation (N-PASS) scale. Secondary outcome measures were tachycardia, bradycardia, desaturations, and crying time.

Conditions

  • Retinopathy of Prematurity
  • Pain Management

Interventions

DRUG

Ibuprofen (Sanofi, Istanbul, Turkey)

Each enrolled infant received oral ibuprofen at a dose of 10 mg/kg 60 min before the onset of the eye examination.

DRUG

Paracetamol (GlaxoSmithKline, Istanbul, Turkey)

Each enrolled infant received oral paracetamol at a dose of 10 mg/kg 60 min before the onset of the eye examination.

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Ozgul Bulut · Medeniyet University Göztepe Training and Research Hospital

Eligibility

Min Age
22 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-07-30
Completion
2020-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767178 on ClinicalTrials.gov