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

Phase 3

Completed

• Conditions: Neonates 30-34 weeks postmenstrual age undergoing screening for retinopathy of prematurity.

• Registration Number: CTRI/2017/12/011016
• Lead Sponsor: Surya Hospital

Brief Summary

Standard pain relief measures used in neonates such as oral sucrose, oral paracetamol, proparacaine eye drops, EBM, non nutritive sucking , swaddling, KMC etc may be inadequate in relieving pain associated with screening  for ROP.

Intranasal fentanyl is a standard analgesic used in children for severe pain.

We hypothesized that administration of fentanyl intranasally in addition to standard pain relief would result in a further 50 % reduction in Pain score (PIPP)in premature neonates undergoing ROP screening . 56 patients would  need to be recruited for a study power of 90% and two tailed alpha of 0.05.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-28
• Study Completion: 2019-07-16
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Neonates 30-34 weeks postmenstrual age undergoing screening for retinopathy of prematurity.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity	1.PIPP score (Premature infant pain profile) during screening for retinopathy of prematurity

Secondary Outcome Measures

Name	Time	Method
1.PIPP score during screening for retinopathy of prematurity	2.PIPP score post laser :time point 1,5,10 minutes post procedure

Trial Locations

Locations (1)

Surya Child Care PVT. LTD; 🇮🇳 (Suburban), MAHARASHTRA, India

Surya Child Care PVT. LTD

🇮🇳(Suburban), MAHARASHTRA, India

Dr jagdish kathwate

Principal investigator

7666490985

docjagdishkat@gmail.com