Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - to reduce the pain associate with rop screening

"Intranasal fentanyl as add-on therapy in screening of retinopathy of prematurity - A double blind randomized control trial." - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055556

Enrollment

Registered

2023-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: Intranasal fentanyl[2Âµg/kg]: (breast milk to be given to child 30 minute before the screening and 0.5% proparacaine eye drop to put 1 minute before screening) standard screening proced

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants heaving gestational age

Exclusion criteria

Exclusion criteria: Unstable neonates ( ventilate) and sedated neonate Neonates with C/I for fentanyl Neonates planned for surgery and neonate with congenital defects, and neurological disfunction

Design outcomes

Primary

Measure	Time frame
-To compare the effects of intranasal fentanyl (I) with standard care (C) in reducing procedural pain related to ROP screening (O) in preterm neonates (P) to be evaluated by the premature infant pain profile - R (PIPP-R) scoreTimepoint: immediately after screening,1 minute after screening,5 minute after screening	—

Secondary

Measure	Time frame
1. . To compare the incidences of ocular and systemic side effect in neonates(due to intra nasal fentanyl) like apneic episodes, need of respiratory support and episodes of bradycardia & desaturation between the groups 2.To compare the time taken to complete the procedure successfully in both Timepoint: patient was kept under abservation for next 24 hour to look out for any ocular and systemic,and local side effect	—

Measure

Time frame

1. . To compare the incidences of ocular and systemic side effect in neonates(due to intra nasal fentanyl) like apneic episodes, need of respiratory support and episodes of bradycardia & desaturation between the groups 2.To compare the time taken to complete the procedure successfully in both Timepoint: patient was kept under abservation for next 24 hour to look out for any ocular and systemic,and local side effect

—

Countries

India

Contacts

Public ContactDr Debasish sadangi

ALL INDIA INSTUTITE OF MEDICAL SCIENCES, BHUBANESWAR

drsandipsahu@yahoo.com7978243970

Outcome results

None listed

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