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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-07-01

Brief Summary

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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

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Detailed Description

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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

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Analgesia Sedation and Analgesia Neonatal Mechanical Ventilation in Neonates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dexmedetomidine and fentanyl

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

fentanyl 0.5 mcg/kg/hr

Intervention Type DRUG

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

fentanyl only

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

Group Type ACTIVE_COMPARATOR

fentanyl 1mcg/kg/hr

Intervention Type DRUG

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

Interventions

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