Ain Shams University Hospitals
Cairo, Egypt
NCT Number: NCT07241351
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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Notify Me1 hour–28 day
All sexes
Interventional
Phase 2 / Phase 3
Cairo, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 as continuous infusion at 1.0 mcg/kg/hr over 24 hours
fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant
Time frame: 24 hours
number of doses of rescue analgesia given during the first 24 hours
Time frame: 24 hours
done hourly to indicate pain and sedation if more than or equal to three patient is in pain
Time frame: 24 hours
development of bradycardia,
Time frame: 24 hours
development of hypotension
Time frame: 24 hours
development of respiratory depression
Ain Shams University
Other
Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation
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