Use of single dose intranasal fentanyl for the reduction of pain associated with retinopathy of prematurity screening :RCT

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/011016

Enrollment

112

Registered

2017-12-28

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 30-34 weeks postmenstrual age undergoing screening 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) : 2

Eligibility

Inclusion criteria

Inclusion criteria: Neonates 30-34 weeks postmenstrual age undergoing screening 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
1. PIPP score (Premature infant pain profile) during screening for retinopathy of prematurityTimepoint: 1. PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity	—

Secondary

Measure	Time frame
1. PIPP score during screening for retinopathy of prematurity 2. PIPP score post laser :time point 1,5,10 minutes post procedure 3. Heart rate at speculum insertion, during procedure, post procedure: time point 1,5,10 minutes. 4. Respiratory rate at speculum insertion, during procedure, post procedure :time point 1,5,10 minutes . 5. Apnea (during and 2 hrs post procedure) 6. Median duration of laser therapy. 7. Crying time post laser. 8. Incidence of Chest wall rigidity. Timepoint: 1,5,10 minutes	—

Measure

Time frame

1. PIPP score during screening for retinopathy of prematurity 2. PIPP score post laser :time point 1,5,10 minutes post procedure 3. Heart rate at speculum insertion, during procedure, post procedure: time point 1,5,10 minutes. 4. Respiratory rate at speculum insertion, during procedure, post procedure :time point 1,5,10 minutes . 5. Apnea (during and 2 hrs post procedure) 6. Median duration of laser therapy. 7. Crying time post laser. 8. Incidence of Chest wall rigidity. Timepoint: 1,5,10 minutes

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Countries

India

Contacts

Public ContactDr Jagdish Kathwate

Surya Child Care PVT. LTD mumbai

docjagdishkat@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 28, 2026