To compare the effect of combined use of intravenous fentanyl and intravenous ketamine against use of intravenous fentanyl for reducing pain associated with the laser photocoagulation procedure done for retinopathy of prematurity in preterm neonates
Phase 3
- Conditions
- Health Condition 1: H351- Retinopathy of prematurity
- Registration Number
- CTRI/2024/04/066305
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All preterm neonates more than 1500g at the time of screening on room air for past 3 days and hemodynamically stable requiring laser photocoagulation for zone 2 ROP
Exclusion Criteria
Major malformations severe birth asphyxia shock
Known chromosomal abnormality
History of chest wall rigidity with fentanyl
by screening the records
History of any opioid use in the last 7 days
Known hydrocephalus or glaucoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of neonates having adequate pain relief defined as PIPP R score less than 7 for at least fifty percentage of the time during the procedureTimepoint: 5 minutes prior to the procedure and then every 15 minutes during the procedure
- Secondary Outcome Measures
Name Time Method To determine occurrence of feed intoleranceTimepoint: Two hourly till twelve hours post procedure;To determine occurrence of hemodynamic instability within twenty four hours of procedureTimepoint: Two hourly till twelve hours post procedure;To determine occurrence of urinary retentionTimepoint: six hourly till twenty four hours post procedure;To determine requirement of ventilatory supportTimepoint: From the start of procedure to twenty four hours after the procedure;To determine the side effect profile of combination of fentanyl infusion and intermittent ketamine bolusTimepoint: All the apneic events will be recorded <br/ ><br>