Pain Management During Screening for Retinopathy of Prematurity
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|ClinicalTrials.gov Identifier: NCT04767178|
Recruitment Status : Completed
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
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.
|Condition or disease||Intervention/treatment|
|Retinopathy of Prematurity Pain Management||Drug: Ibuprofen (Sanofi, Istanbul, Turkey) Drug: Paracetamol (GlaxoSmithKline, Istanbul, Turkey)|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Oral Ibuprofen Versus Oral Paracetamol in Pain Management During Screening for Retinopathy of Prematurity: A Prospective Observational Study|
|Actual Study Start Date :||January 1, 2020|
|Actual Primary Completion Date :||July 30, 2020|
|Actual Study Completion Date :||August 15, 2020|
Infants that received oral ibuprofen were categorized into the ibuprofen group
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.
Other Name: Dolven
Infants that received oral paracetamol were categorized into the paracetamol group
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.
Other Name: Parol
- The Neonatal Pain, Agitation, and Sedation scale [ Time Frame: 8 month ]The mean of the Neonatal Pain, Agitation, and Sedation score (A score >+3 indicates pain)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767178
|Istanbul, Turkey, 34674|
|Principal Investigator:||Ozgul Bulut||Medeniyet University Göztepe Training and Research Hospital|