A Phase 2/3 interventional study of Dexmedetomidine and fentanyl 1mcg/kg/hr in Analgesia, Sedation and Analgesia and Neonatal, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 1 Hour to 28 Days. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
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
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
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Exclusion Criteria:
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
Drug: Dexmedetomidine · Drug: fentanyl 0.5 mcg/kg/hr
fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24
Drug: fentanyl 1mcg/kg/hr
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
need for additional rescue analgesia
number of doses of rescue analgesia given during the first 24 hours
Time frame: 24 hours
NPASS ( neonatal pain , agitation and sedation score)
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,
development of bradycardia,
Time frame: 24 hours
development of hypotension
development of hypotension
Time frame: 24 hours
development of respiratory depression
development of respiratory depression
Time frame: 24 hours
Plan to share: Yes — data can be shared from the corresponding author upon reasonable request
Supporting information: Study protocol
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Ain Shams University