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

Phase 3

Not yet recruiting

• Conditions: Neonates 32-44 weeks postmenstrual age undergoing laser photocoagulation for retinopathy of prematurity

• Registration Number: CTRI/2017/12/011035
• Lead Sponsor: Surya Childrens Medicare Pvt Ltd Hospital

Brief Summary

Laser  therapy in premature neonates is associated with significant pain due to eyelid speculum placement for a period of 20-30 min. 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 laser therapy 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 35% reduction in Pain score (PIPP)in premature neonates undergoing laser therapy. 23 patients would  need to be recruited for a study power of 80% and two tailed alpha of 0.05.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-12-28
• Study Start: 2018-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1.Neonates 32-44 weeks postmenstrual age undergoing laser photocoagulation 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
PIPP score (Premature infant pain profile) during laser photocoagulation	Every 10 minutes during procedure

Secondary Outcome Measures

Name	Time	Method
PIPP score,HR,RR	1 ,5,10 minutes

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