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In this study we compare two different drugs dexmedetomidine and ketamine with paracetamol to see their ability to reduce pain in children born before completion of term undergoing laser photocoagulation surgeries for retinopathy of prematurity

Opioid free analgesia using Dexmedetomidine vs Ketamine in infants with Retinopathy of Prematurity undergoing laser photocoagulation surgeries

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089808
Enrollment
54
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: DEXMEDETOMIDINE: Dexmedetomidine administered as a loading dose of 0.5 mcg/kg in first 10 mins followed by a continuous infusion of 0.7 mcg/kg/hr which will be titrated based on haemody

Sponsors

Director of Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants less than 37 weeks of gestational age diagnosed with ROP requiring laser treatment.

Exclusion criteria

Exclusion criteria: 1. Infants with contraindications to dexmedetomidine or ketamine. 2. Infants already on any type of respiratory support or sick enough to be in NICU. 3. Infants with any congenital abnormalities. 4. Refusal to take part in study.

Design outcomes

Primary

MeasureTime frame
To compare pain scores at 5 mins post laser photocoagulation surgeries in infants using premature infant pain profile(PIPP).Timepoint: 1min, 5 mins,10mins,30mins post laser photocoagulation surgeries in infants using premature infant pain profile(PIPP).

Secondary

MeasureTime frame
To compare intraoperative hemodynamic stability, adverse effects (apnea,bradycardia) and the time of awakening post procedure.Timepoint: Baseline, every 5 mins intraoperatively postoperatively till 30 mins.

Countries

India

Contacts

Public ContactDr Tanvir Samra

Post Graduate Institute of Medical Education and Research

drtanvirsamra@yahoo.in7087262379

Outcome results

None listed

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