drugset / Trial / NCT05324891

Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

NCT05324891

Phase 2 Completed 40 enrolled Mansoura University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences. Fentanyl is a widely used analgesic which promotes rapid analgesia,however, is not free of adverse effects including chest wall rigidity, hypothermia, hypotension, respiratory depression and tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation, anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in postoperative mechanically ventilated neonates.

Timeline

Start
2016-01
Primary completion
2017-08
Completion
2017-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.3 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous

Indications

No indication recorded.