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pain control in preterm infants

Comparing the efficacy of oral sucrose andacetaminophen in pain relief for ophthalmologic screening of retinopathy of prematurity in preterm infants

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201206303915N5
Enrollment
120
Registered
2012-07-16
Start date
2012-06-21
Completion date
Unknown
Last updated
2018-02-22

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: group 1: 0.2ml/kg sucrose 20%. Intervention 2: group2: Acetaminophen drop 0-2 ml/kg weight. Intervention 3: group 3: 0.2 ml/kg distilled water (placebo).
Treatment - Drugs
Placebo
group 1: 0.2ml/kg sucrose 20%
group2: Acetaminophen drop 0-2 ml/kg weight
group 3: 0.2 ml/kg distilled water (placebo)

Sponsors

Research vice chancellor of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:infants with gestational age 32 weeks or less or gestational age 32-34 weeks with unstable clinical course; eye examination in Alzahra hospital during hospital stay and no any major congenital anomaly. Exclusion criteria: major congenital anomalies; chromosomal anomaly and severe perinatal asphyxia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: during examination. Method of measurement: PIPP pain scoring.

Secondary

MeasureTime frame
Oxygen requirement. Timepoint: 5, 10, 15, 20, minutes after examination. Method of measurement: pulse oximetry.;Apnea. Timepoint: 5, 10, 15 and 20 minute after examination till 24 hours. Method of measurement: pulse oxymetry and clinical monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Seifi, MD

Tabriz University of Medical Sciences

fmseifi@yahoo.com+98 41 1553 9161

Outcome results

None listed

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