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Comparison between two sedative agents in neonates requiring ventilator support

Dexmedetomidine versus Fentanyl for sedation and analgesia in ventilated neonates an open labelled pilot randomized controlled study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103769
Enrollment
100
Registered
2026-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified

Interventions

Intervention1: Dexmedetomidine: Inj Dexmedetomidine will start at 0.2 g per kg per hr Assessment of sedation level will be done every 30mins with comfort neo pain scale. If score is less than 14, Con

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestation age between 28 weeks to 44 weeks Mechanically ventilated with Ventilation asynchrony or COMFORTneo score more than 14

Exclusion criteria

Exclusion criteria: Neonates who had received opioids, benzodiazepine 12 hours before ventilation Moderate to severe encephalopathy IVH more than Grade 2 Imminent death or critically sick at time of recruitment Major life threatening malformation Post surgical cases

Design outcomes

Primary

MeasureTime frame
Proportion of time neonates remaining with in target sedation range that is comfortneo score less than 14Timepoint: 96 hours from time of ventilation initiation.

Secondary

MeasureTime frame
Need for additional sedation Duration of sedation Duration of mechanical ventilationTimepoint: 96 hours from time of ventilation initiation.

Countries

India

Contacts

Public ContactVijay Kumar K

IMS and SUM Hospital

vijaykumark@soa.ac.in7838694243

Outcome results

None listed

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