Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT05324891

Ms/15.05.90

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 1 hour to 4 weeks old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Fentanyl

Active Comparator group

Description:

Neonates received fentanyl infusion during postoperative phase.

Treatment:

Drug: Fentanyl

Dexmedetomidine

Active Comparator group

Description:

Neonates received dexmedetomidine infusion during postoperative phase.

Treatment:

Drug: Dexmedetomidine