Clinical trial NCT05324891: Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates
Official title: Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A prospective, randomized trial, which was conducted upon neonates who needed postoperative mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's Hospital.The patients were randomized to two groups according to the drug they received for postoperative sedation. The first group received dexmedetomidine infusion and the second group received fentanyl infusion.Our primary outcome was the efficacy of postoperative sedation score, and the secondary outcomes were plasma cortisol level, time to extubation, time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant, length of the hospital stay, side effects of sedative drugs and mortality.

Eligibility criteria: Inclusion Criteria:

* Neonates need postoperative ventilation.

Exclusion Criteria:

1. Major congenital cardiovascular anomalies.
2. Chromosomal anomalies.
3. Grade IV intraventricular hemorrhage.
4. Tracheoesophageal fistula with wide gap (distance between proximal and distal end more than two centimeters).

Primary outcomes:
measure: The efficacy of postoperative sedation according to pain score.
timeFrame: upto five days after surgical intervention
Secondary outcomes:
measure: Plasma cortisol level
timeFrame: Within 48 hours after surgical intervention
measure: Need of adjuvant analgesics or sedatives
timeFrame: upto five days after surgical intervention
measure: Need of skeletal muscle relaxant
timeFrame: upto five days after surgical intervention
measure: Time to extubation.
timeFrame: upto 21 days postoperative
measure: Time to reach 100ml/kg/day enteral feed.
timeFrame: upto 21 days postoperative
measure: Length of hospital stay.
timeFrame: upto 30 days postoperative
measure: Mortality
timeFrame: upto 21 days postoperative
measure: Adverse effects of the sedative drugs
timeFrame: upto seven days after surgical intervention
measure: Culture-proven sepsis
timeFrame: upto 30 days after surgical intervention
Other outcomes:
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