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

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Analgesia; Mechanical Ventilation in Neonates; Neonatal; Sedation and Analgesia

Treatments: Drug: fentanyl 0.5 mcg/kg/hr; Drug: fentanyl 1mcg/kg/hr; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07241351

Dexmedetomidine as an Adjunct

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full term neonates (≥ 37 weeks gestational age)
• Age: 1 to 28 days.
• Neonates just started invasive mechanical ventilation and are going to start sedation.

Exclusion criteria

• Presence of central nervous system abnormality
• Complex multiple congenital anomalies
• Neonates with facial malformations
• Neonates on mechanical Ventilation setting (peep above 9)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

dexmedetomidine and fentanyl

Experimental group

Description:

fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant 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

Treatment:

Drug: Dexmedetomidine

Drug: fentanyl 0.5 mcg/kg/hr

fentanyl only

Active Comparator group

Description:

fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24

Treatment:

Drug: fentanyl 1mcg/kg/hr