Analgesia, Mechanical Ventilation in Neonates, Neonatal, Sedation and Analgesia
Conditions
Keywords
sedation, analgesia, full term neonates, dexmedetomidine, fentanyl, adjuvant
Brief 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
Interventions
DRUGDexmedetomidine
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
DRUGfentanyl 1mcg/kg/hr
fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours
DRUGfentanyl 0.5 mcg/kg/hr
fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| need for additional rescue analgesia | 24 hours | number of doses of rescue analgesia given during the first 24 hours |
| NPASS ( neonatal pain , agitation and sedation score) | 24 hours | done hourly to indicate pain and sedation if more than or equal to three patient is in pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| development of bradycardia, | 24 hours | development of bradycardia, |
| development of hypotension | 24 hours | development of hypotension |
| development of respiratory depression | 24 hours | development of respiratory depression |
Countries
Egypt
Outcome results
None listed