To compare fentanyl and ketamine as pain relief agent in preterm babies requiring laser treatment for retinopathy of prematurity(ROP)

Fentanyl versus ketamine for analgesia during laser treatment for retinopathy of prematurity(ROP) in preterm infants- An interventional case series study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012878

Enrollment

124

Registered

2018-03-27

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- Retinopathy of prematurity

Interventions

Intervention1: Ketamine: Establish intravenous access under strict aseptic precautions.Give bolus dose of ketamine at 0.5 mg/kg 1 minute prior to procedure.All infants allocated to ketamine group will

Eligibility

Inclusion criteria

Inclusion criteria: All preterm infants attending clinic at RP Center for laser therapy for ROP a) Declared fit for undergoing laser therapy b) Anticipated duration of procedure > 30 minutes c) Hemodynamically stable d) No anemia( PCV >30) e) Absence of major morbidities [Grade III-IV intraventricular hemorrhage(IVH), (patent ductus arteriosus(PDA), necrotizing enterocolitis(NEC)]

Exclusion criteria

Exclusion criteria: a) Babies with congenital malformations b) Babies already on CPAP, MV or sick enough to require NICU care c) Babies with hypertension

Design outcomes

Primary

Measure	Time frame
1. Revised PIPP score 5 minutes before and then every 15 minutes during the procedure in preterm infants undergoing laser photocoagulation for ROP 2. Total duration of cry/ % cry time during procedure Timepoint: 5 minute before and every 15 minutes during the procedure	—

Secondary

Measure	Time frame
Need for NICU/HDU admission for 24 hours or more post procedure as defined by any of the following a) Change in mean cardiorespiratory stability scores after procedure requiring upgradation of respiratory support b) Hemodynamic instability within 24 hours of procedure requiring fluid boluses or vasoactive support c) Intolerance to feeds post procedure d) Urinary retention requiring bladder catheterization e) Repeated episodes of apnea Timepoint: 24 hours post procedure	—

Measure

Time frame

Need for NICU/HDU admission for 24 hours or more post procedure as defined by any of the following a) Change in mean cardiorespiratory stability scores after procedure requiring upgradation of respiratory support b) Hemodynamic instability within 24 hours of procedure requiring fluid boluses or vasoactive support c) Intolerance to feeds post procedure d) Urinary retention requiring bladder catheterization e) Repeated episodes of apnea Timepoint: 24 hours post procedure

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Countries

India

Contacts

Public ContactShamnad M

All India Institute of Medical Sciences, New Delhi

ra.aiims@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026