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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine and fentanyl | Experimental | 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 |
|
| fentanyl only | Active Comparator | fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| need for additional rescue analgesia | number of doses of rescue analgesia given during the first 24 hours | 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| development of bradycardia, | development of bradycardia, | 24 hours |
| development of hypotension | development of hypotension | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mariam JA ibrahim, PHD | Ain Shams University | Principal Investigator |
| Rouzan A Nassar, MBBCH | MOHP Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Egypt |
data can be shared from the corresponding author upon reasonable request
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| fentanyl 1mcg/kg/hr | Drug | fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours |
|
| fentanyl 0.5 mcg/kg/hr | Drug | fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant |
|
| development of respiratory depression | development of respiratory depression | 24 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |