Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

NCT05324891 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Ms/15.05.90
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The efficacy of postoperative sedation according to pain score.

  Assessment of Neonatal Pain, Agitation and Sedation Scale immediately after the operations then every 12 hours till 5 days

  upto five days after surgical intervention

Secondary Outcomes (9)

• Plasma cortisol level

  Within 48 hours after surgical intervention

• Need of adjuvant analgesics or sedatives

  upto five days after surgical intervention

• Need of skeletal muscle relaxant

  upto five days after surgical intervention

• Time to extubation.

  upto 21 days postoperative

• Time to reach 100ml/kg/day enteral feed.

  upto 21 days postoperative

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Neonates received fentanyl infusion during postoperative phase.

Drug: Fentanyl

Dexmedetomidine

ACTIVE COMPARATOR

Neonates received dexmedetomidine infusion during postoperative phase.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine 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.

Dexmedetomidine

Fentanyl 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.

Fentanyl

Eligibility Criteria

• Age: 1 Hour - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates need postoperative ventilation.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 30, 2017
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share