Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries

NCT06994273 | Completed

• 1 other identifier: 36264PR315/8/23
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.

Conditions

Analgesic; Sedative; Fentanyl; Dexmedetomidine; Infusion; Postoperative; Mechanical Ventilation; Children; Open Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

• Weaning eligibility

  The time from ventilator weaning eligibility was monitored until discharge.

  48 hours postoperatively

Secondary Outcomes (3)

• Time from eligibility to extubation

  60 min postoperatively

• Mean arterial pressure

  48 hours post-infusion initiation

• Heart rate

  48 hours post-infusion initiation

Study Arms (2)

Fentanyl group

EXPERIMENTAL

Patients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes

Drug: Fentanyl

Dexmedetomidine group

EXPERIMENTAL

Patients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes.

Drug: Dexmedetomidine

Interventions

Fentanyl DRUG

Patients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes.

Fentanyl group

Dexmedetomidine DRUG

Patients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes.

Dexmedetomidine group

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 4 to 11 years.
• Both sexes.
• Children who required a minimum of 24 hrs of mechanical ventilation following open abdominal surgeries

You may not qualify if:

• Patients with significant congenital anomalies.
• Chromosomal abnormalities.
• Neurologic conditions prohibiting sedation evaluation.
• Neuromuscular diseases.
• Those receiving neuromuscular blockers

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Abotaleb AM, Elsheikh MR, Elshimy KM, AbdelFattah ME. Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Postoperative Mechanically Ventilated Children After Open Abdominal Surgeries: Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Jul 3;2025:9699738. doi: 10.1155/anrp/9699738. eCollection 2025.

  PMID: 40642177 DERIVED

MeSH Terms

Interventions

Fentanyl; Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)