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Dexmedetomidine Versus Midazolam for Sedation in Mechanically Ventilated Neonates: A Comparative Study Using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS)

Dexmedtomidine Versus Midazolam for Sedation in Mechanically Ventilated Neonates: A Comparative Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001700
Enrollment
Unknown
Registered
2026-07-06
Start date
2025-06-25
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Mechanical ventilation

Interventions

dexmedetomidine :Dexmedtomidine

Sponsors

University of Baghdad
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Years to 36 Years

Inclusion criteria

Inclusion criteria: Neonates were eligible for inclusion if they met all of the following criteria: (a) gestational age between 28 and 36 weeks at birth; (b) admission to the NICU awith a clinical indication for invasive mechanical ventilation; (c) anticipated duration of mechanical ventilation of at least 24 hours; and (d) informed verbal consent obtained from a parent or legal guardian.

Exclusion criteria

Exclusion criteria: Neonates were excluded if any of the following conditions were present: (a) major congenital anomalies, including significant cardiac malformations, neurological abnormalities, or syndromic conditions; (b) severe hemodynamic instability requiring high-dose inotropic or vasopressor support (defined as the need for more than one vasoactive agent or a single agent at a dose exceeding standard thresholds); (c) known or suspected hypersensitivity to dexmedetomidine or midazolam; (d) preexisting renal or hepatic impairment that could significantly alter drug metabolism or clearance.

Design outcomes

Primary

MeasureTime frame
depth of sedation ;

Secondary

MeasureTime frame
Pain scores;Duration of mechanical ventilation;Heart rate;Bradycardia;Need for rescue analgesia;Time to NICU discharge;

Countries

Iraq

Contacts

Public ContactAli Mohammed

Children Welfare Teaching Hospital

dr.alihussainmohammed@gmail.com+964 770 794 3832

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026