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A clinical study to compare the effect of fentanyl and oral sucrose in providing optimal pain relief in preterm babies during laser therapy for retinopathy of prematurity

Low dose fentanyl infusion versus oral sucrose for pain management during laser treatment for retinopathy of prematurity (ROP) â?? An open label randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/008977
Enrollment
58
Registered
2017-07-05
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- Preterm infants retinopathy of prematurity(ROP)requiring laser photocoagulation

Interventions

Intervention1: Injection fentanyl as an analgesic agent during laser photocoagulation: Dose:1 micro-gram/kg/hour as infusion starting 2 minutes before the procedure (Low dose infusion) Control Interv

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)Declared fit for undergoing laser photocoagulation b)Parents consented for 24 hospitalization period after procedure in the neonatal unit at AIIMS New Delhi

Exclusion criteria

Exclusion criteria: a) Major congenital malformations b) Anticonvulsants/sedatives prior to the procedure or within 24 hrs of the procedure c) Neonatal cholestasis

Design outcomes

Primary

MeasureTime frame
To compare the effect of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief, as assessed by duration of cry during the procedure, in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP)Timepoint: To compare the effect of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief, as assessed by duration of cry during the procedure, in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP)—

Secondary

MeasureTime frame
To compare the effect of low dose fentanyl infusion and 24 % oral sucrose on incidence of feed intolerance in the first 24 hours after the procedureTimepoint: By measuring abdominal girth (AG) at a fixed place above the umbilicus each time before feeding 2 Hourly till 24 hours post procedure;To compare the effect of low dose fentanyl infusion and 24 % oral sucrose on the incidence of apnea and need for mechanical ventilation in the first 24 hours after the procedure, in preterm infants undergoing laser photocoagulation for ROPTimepoint: All apneic events during the procedure and in the first 24 hours after the procedure will be recorded;To compare the effect of low dose fentanyl infusion and 24 % oral sucrose on the incidence of urinary retention requiring catheterization of the bladder in the first 24 hours after the precedureTimepoint: 6 Hourly till 24 hours post procedure;To compare the effect of low dose fentanyl infusion and 24 % oral sucrose on stress, as assessed by salivary cortisol levels, before and after the procedure, in preterm infants undergoing laser photocoagulation for ROPTimepoint: Three times 30 minutes before and then 30 minutes and 4 hours after the laser photocoagulation for ROP ;To compare the effect of low dose fentanyl infusion and 24 % oral sucrose on pain during the procedure, as assessed by revised Premature infant pain profile (PIPP score)in preterm infants undergoing laser photocoagulation for ROPTimepoint: 5 minutes before the procedure(baseline) and then every 10 minutes during the procedure—

Countries

India

Contacts

Public ContactDr M Jeeva Shankar

All India Institute of Medical Sciences (AIIMS)

jeevasankar@gmail.com9818398928

Outcome results

None listed

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