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Comparing dexmedtomidine with fentanyl infusion in better sedation in preterm neonates- a randomized control trial

Comparing dexmedtomidine vs fentanyl infusion in effective sedation in preterm neonates- a randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073301
Enrollment
30
Registered
2024-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: P28- Other respiratory conditions originating in the perinatal period Health Condition 2: P22- Respiratory distress of newborn

Interventions

Intervention1: dexmedtomidine therapy: dexmedtomidine therapy for effective pain relief and sedation in preterm neonates requiring pharmacotherapy for pain relief with NPASS more than 3,started with d

Sponsors

Institute Neotia Getwel Healthcare Centre Dept of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: preterm (28-37 weeks),post natal age less than 28 days Requiring Respiratory support Requiring pain management with pharmacotherapy as per Pain score (NPASS) more than 3

Exclusion criteria

Exclusion criteria: Severe Neurological Issue Congenital Anomaly Any contraindication for starting pain pharmacotherapy (No intestinal peristaltic sounds, Hypotension ,Bradycardia)

Design outcomes

Primary

MeasureTime frame
Cumulative Duration of SedationTimepoint: at 1 wk after randomization—

Secondary

MeasureTime frame
Days to Reach full feedTimepoint: at 1 wk and 2 wk and 3 wk;Duration of Respiratory supportTimepoint: at 1 wk and 2wk after randomization;Late onset sepsisTimepoint: any time prior to discharge;Requiring Adjunctive sedative medicationTimepoint: any time prior to discharge;Sedative medication stopped prematurely due to side effectsTimepoint: any time prior to discharge;With drawl symptomsTimepoint: any time prior to discharge—

Countries

India

Contacts

Public ContactDr Aritra Ray

Neotia Getwel Healthcare Centre

aritraray.sunny1988@gmail.com9641632917

Outcome results

None listed

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