Pain Management During Screening for Retinopathy of Prematurity

NCT04767178 | Completed

• 1 other identifier: Ozgul1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Analgesia; ibuprofen; N-PASS; pain management; paracetamol; preterm infant; retinopathy of prematurity

Outcome Measures

Primary Outcomes (1)

• The Neonatal Pain, Agitation, and Sedation scale

  The mean of the Neonatal Pain, Agitation, and Sedation score (A score \>+3 indicates pain)

  8 month

Study Arms (2)

Ibuprofen group

Infants that received oral ibuprofen were categorized into the ibuprofen group

Drug: Ibuprofen (Sanofi, Istanbul, Turkey)

Paracetamol group

Infants that received oral paracetamol were categorized into the paracetamol group

Drug: Paracetamol (GlaxoSmithKline, Istanbul, Turkey)

Interventions

Ibuprofen (Sanofi, Istanbul, Turkey) DRUG

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

Also known as: Dolven

Ibuprofen group

Paracetamol (GlaxoSmithKline, Istanbul, Turkey) DRUG

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

Also known as: Parol

Paracetamol group

Eligibility Criteria

• Age: 22 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The present study enrolled preterm infants with a gestational age of ≤32 weeks or birth weight ≤ 1500 g who were screened for ROP.

You may qualify if:

• Preterm infants of ≤32 weeks of gestational
• Preterm infants ≤ 1500 gram of birth weight

You may not qualify if:

• Major congenital abnormalities
• Neurological dysfunction
• Infants who were mechanically ventilated and/or sedated, hemodynamically unstable
• Infants \> 32 weeks of gestational
• The infants whose parents denied consent were also not included.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Medeniyet University

Istanbul, 34674, Turkey (Türkiye)

Location

Related Publications (1)

• Bulut O, Tarak Bozkurt O, Arslanoglu S. Oral Ibuprofen Versus Oral Paracetamol in Pain Management During Screening for Retinopathy of Prematurity: A Prospective Observational Study. J Perinat Neonatal Nurs. 2022 Jul-Sep 01;36(3):305-311. doi: 10.1097/JPN.0000000000000675.

  PMID: 35894729 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Agnosia; Premature Birth

Interventions

Ibuprofen; Acetaminophen; halofantrine

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Ozgul Bulut

  Medeniyet University Göztepe Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 23, 2021
• Study Start: January 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: August 15, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)