The effect of acetaminophen and dextrose on reducing neonatal pain

Efficacy of Oral Dextrose versus Acetaminophen on Pain relif During Retinopathy of Prematurity (ROP) Eye Examinations : A Randomized Controlled double blind clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210710051836N1

Enrollment

140

Registered

2021-10-03

Start date

2020-03-20

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Retinopathy of prematurity. Retinopathy of prematurity

Interventions

Intervention 1: Intervention group: Acetaminophen receiving group was received 3 drops/kg or 15 mg/kg of 100 mg oral acetaminophen 60 min before eye examination. Intervention 2: Intervention group:Dex

Eligibility

Sex/Gender

All

Age

28 Days to 42 Days

Inclusion criteria

Inclusion criteria: premature neonates with birth weight = 2000 g gestational age between 28 and 34 weeks first screening examination postnatal age between 28 and 42 days.

Exclusion criteria

Exclusion criteria: use of sedative medications congenital anomaly neurological disorders Dissatisfaction of parents

Design outcomes

Primary

Measure	Time frame
Pain score using the pipp scale. Timepoint: Before the start of the retinopathy of prematurity examination and 30 seconds after the examination. Method of measurement: In order to measure pain, premature infant pain profile (PIPP) is identified as a common tool for behavioral, physiological (heart rate and oxygen saturation) and contextual (gestational age and behavioral state) indicators. Behavioral items are categorized into three facial actions: brow bulge, eye squeeze, and nasolabial furrow.	—

Measure

Time frame

Pain score using the pipp scale. Timepoint: Before the start of the retinopathy of prematurity examination and 30 seconds after the examination. Method of measurement: In order to measure pain, premature infant pain profile (PIPP) is identified as a common tool for behavioral, physiological (heart rate and oxygen saturation) and contextual (gestational age and behavioral state) indicators. Behavioral items are categorized into three facial actions: brow bulge, eye squeeze, and nasolabial furrow.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Riyahi

Kerman University of Medical Sciences

H.ehtemam@gmail.com+98 34 3246 0284

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026