NCT07241351

Dexmedetomidine as an Adjunct to Fentanyl for Term Neonates on Mechanical Ventilation

Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Not accepted

Summary

Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine

Detailed description

Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion. In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine

Conditions

• Analgesia
• Sedation and Analgesia
• Neonatal
• Mechanical Ventilation in Neonates

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates \<14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age
DRUG	fentanyl 1mcg/kg/hr	fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours
DRUG	fentanyl 0.5 mcg/kg/hr	fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-11-01
• Completion: 2025-07-01
• First posted: 2025-11-21
• Last updated: 2025-12-02

Locations

1 site across 1 country: Egypt