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

combination of intravenous fentanyl and ketamine vs intravenous fentanyl for analgesia during laser photocoagulation in retinopathy of prematurity in preterm neonates: A randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066305

Enrollment

104

Registered

2024-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Combination of intravenous fentanyl and ketamine: Intravenous loading dose of fentanyl (2 mcg/kg) and ketamine (0.5 mg/kg) bolus followed by intravenous fentanyl infusion of 2 mcg/kg/ho

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To determine the side effect profile of combination of fentanyl infusion and intermittent ketamine bolusTimepoint: All the apneic events will be recorded ;To determine occurrence of feed intoleranceTimepoint: Two hourly till twelve hours post procedure;To determine requirement of ventilatory supportTimepoint: From the start of procedure to twenty four hours after the procedure;To determine occurrence of urinary retentionTimepoint: six hourly till twenty four hours post procedure;To determine occurrence of hemodynamic instability within twenty four hours of procedureTimepoint: Two hourly till twelve hours post procedure	—

Measure

Time frame

To determine the side effect profile of combination of fentanyl infusion and intermittent ketamine bolusTimepoint: All the apneic events will be recorded ;To determine occurrence of feed intoleranceTimepoint: Two hourly till twelve hours post procedure;To determine requirement of ventilatory supportTimepoint: From the start of procedure to twenty four hours after the procedure;To determine occurrence of urinary retentionTimepoint: six hourly till twenty four hours post procedure;To determine occurrence of hemodynamic instability within twenty four hours of procedureTimepoint: Two hourly till twelve hours post procedure

—

Countries

India

Contacts

Public ContactBairapaga Harshini

All India Institute Of Medical Sciences

ankitvmmc@yahoo.co.in8447343609

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026