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Head-to-head comparison of Two Medicines (Dexmedetomidine vs. Morphine) to Help Comfort Newborns on Breathing Machines

Comparative efficacy of Dexmedetomidine versus Morphine for pain control in mechanically ventilated neonates greater than and/or equal to 28 weeks gestation: an open label pilot randomised controlled trial (DEXTER) - DEXTER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101747
Enrollment
120
Registered
2026-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P285- Respiratory failure of newborn

Interventions

Intervention1: Dexmedetomidine: Loading Dose: 0.05 0.2 microgram/kg over 10 to 20 minutes Maintenance infusion Dose: 0.1 to 0.5 microgram/kg/hour Control Intervention1: Morphine: Loading dose: 1

Sponsors

AIIMS NAGPUR (Intramural project)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Comparison of pain scores between the 2 groups (morphine and dexmedetomidine) using N-PASS scale

Exclusion criteria

Exclusion criteria: Presence of any of the following conditions, will lead to exclusion of the case from the study: 1.) Babies with birth weight less than 500 grams 2.) Babies with cardiac rhythm abnormalities (e.g. arrhythmia) 3.) Surgical conditions in neonates 4.) Babies with brain malformations

Design outcomes

Primary

MeasureTime frame
Comparison of pain scores between the 2 groups (morphine and dexmedetomidine) using N-PASS scaleTimepoint: Comparison of pain scores between the 2 groups (morphine and dexmedetomidine) using N-PASS scale at start, during ventilation and before extubation—

Secondary

MeasureTime frame
Comparison of requirement of adjunct pharmacotherapy for sedation and/or analgesia in the two groupsTimepoint: at start, then every 6 hours till mechanical ventilation, & then before extubation;Comparison of incidence of accidental extubation in the two groups Timepoint: at start, then every 6 hours till mechanical ventilation, & then before extubation;Comparison of incidence of requirement of vasopressor/inotropic agents in the two groups Timepoint: at start, then every 6 hours till mechanical ventilation, & then before extubation;Comparison of duration of mechanical ventilation in the two groupsTimepoint: Before Discharge—

Countries

India

Contacts

Public ContactDr Sanjana Somanath

AIIMS NAGPUR

sanjana.hs@aiimsnagpur.edu.in8940011358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026