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

Phase 2/3

Completed

• Conditions: Retinopathy of prematurity

• Registration Number: CTRI/2018/03/012878
• Lead Sponsor: Division of Neonatology

Brief Summary

Laser photocoagulation of retina has now become the standard of care for retinopathy of prematurity (ROP) in preterm infants. It is a stressful and painful procedure. However little attention is paid towards strategies for pain reduction in neonates. The standard of care for analgesia during laser treatment is either general anesthesia (GA) or a combination of sedation, analgesia and paralysis (SAP). Due to lack of adequately trained personnel and huge patient load, most of the neonatal units in India are doing laser therapy without any pharmacological analgesia or general anaesthesia so as to avoid mechanical ventilation. A recent RCT conducted in our unit which evaluated the efficacy of low dose opioid(fentanyl) infusion compared to 24% dextrose during ROP laser photocoagulation showed that although opioid analgesia was superior, proportion of time spent during crying and pain scores assessed by premature infant pain profile (PIPP) scores were still higher even with low dose opioid infusion. That is why this study is being done to determine the efficacy and safety of fentanyl infusion and ketamine sedation as a potential regime for reduction of pain associated with laser photocoagulation for ROP without increasing need for ventilation and duration of hospital stay in these infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-04
• Study Completion: 2019-10-05
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 Delhi, DELHI, India

AIIMS, New Delhi

🇮🇳Delhi, DELHI, India

Shamnad M

Principal investigator

9990048228

shamnadmadathil@gmail.com