Use of single dose intranasal fentanyl for the reduction of pain in laser photocoagulation for retinopathy of prematurity : a RCT

Single dose intranasal fentanyl for the reduction of pain associated with laser therapy for retinopathy of prematurity : a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/011035

Enrollment

Registered

2017-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Neonates 32-44 weeks postmenstrual age undergoing laser photocoagulation for retinopathy of prematurity

Interventions

Intervention1: Intranasal Fentanyl (50mcg/ml) at a dose of 2 mcg / kg (diluted to 0.2 ml, 0.1 ml to each nostril) five minutes before eye examination Available as Fenstud (Rusan Parma Ltd, India) : 1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates 32-44 weeks postmenstrual age undergoing laser photocoagulation for retinopathy of prematurity

Exclusion criteria

Exclusion criteria: 1. Infant receiving sedation or analgesic medications for any reason. 2. Infants on mechanical ventilation. 3. Any congenital malformations, or neurological dysfunction. 4. Parents refusing consent.

Design outcomes

Primary

Measure	Time frame
PIPP score (Premature infant pain profile) during laser photocoagulationTimepoint: Every 10 minutes during procedure	—

Secondary

Measure	Time frame
PIPP score,HR,RRTimepoint: 1 ,5,10 minutes	—

Countries

India

Contacts

Public ContactDr Nandkishor S Kabra

Surya hospital

docjagdishkat@gmail.com7666490985

Outcome results

None listed

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