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Pain Management During Screening for Retinopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767178
Recruitment Status : Completed
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Ozgul Bulut, Istanbul Medeniyet University

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.


Condition or disease Intervention/treatment
Retinopathy of Prematurity Pain Management Drug: Ibuprofen (Sanofi, Istanbul, Turkey) Drug: Paracetamol (GlaxoSmithKline, Istanbul, Turkey)

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Ibuprofen group
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

Paracetamol group
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




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   22 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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Turkey
Medeniyet University
Istanbul, Turkey, 34674
Sponsors and Collaborators
Istanbul Medeniyet University
Investigators
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Principal Investigator: Ozgul Bulut Medeniyet University Göztepe Training and Research Hospital
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Responsible Party: Ozgul Bulut, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT04767178    
Other Study ID Numbers: Ozgul1
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozgul Bulut, Istanbul Medeniyet University:
Analgesia
ibuprofen
N-PASS
pain management
paracetamol
preterm infant
retinopathy of prematurity
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Acetaminophen
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics