Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

NCT ID: NCT05324891

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-08-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl

Neonates received fentanyl infusion during postoperative phase.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Infants received Fentanyl IV continuous infusion: 1µg/ kg /hour. Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Dexmedetomidine

Neonates received dexmedetomidine infusion during postoperative phase.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Infants received dexmedetomidine IV loading dose: 0.5 mcg/kg given over 20 minutes followed by maintenance dose 0.3 µg/kg/hour by infusion over 24 hours.Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Interventions

Dexmedetomidine

Infants received dexmedetomidine IV loading dose: 0.5 mcg/kg given over 20 minutes followed by maintenance dose 0.3 µg/kg/hour by infusion over 24 hours.Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Intervention Type: DRUG

Fentanyl

Infants received Fentanyl IV continuous infusion: 1µg/ kg /hour. Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Ms/15.05.90

Identifier Type: -

Identifier Source: org_study_id