Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211225053512N1

Enrollment

300

Registered

2022-12-07

Start date

2022-12-19

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Pain reduction in the eye examination of premature babies..

Interventions

Intervention 1: Intervention group 1: The non-pharmacological group of SADDLING babies - pacifiers and oral sucrose 25% half cc per kilogram of weight. Intervention 2: Intervention group 2: Ketamine 2

Eligibility

Sex/Gender

All

Age

No minimum to 37 Months

Inclusion criteria

Inclusion criteria: Be hemodynamically stable Be alert And be able to tolerate 25% oral sucrose At least one hour has passed since the feeding The examination will also be done before the next meal

Exclusion criteria

Exclusion criteria: The baby of an addicted mother Taking sedative before examination Connected to the ventilator

Design outcomes

Primary

Measure	Time frame
Gestational age. Timepoint: After the examination, the vital signs are monitored for 24 hours. Method of measurement: Premature infant pain profile.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Razi

Shahid Beheshti University of Medical Sciences

mahdiyeh_hospital@sbmu.ac.ir+98 21 5506 2628

Outcome results

None listed

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