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Completed

NCT Number: NCT06994273

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

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

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Key information

Conditions

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

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Appropriate sedation and analgesia are essential components in the post-operative care of critically ill children in the pediatric intensive care unit (PICU), especially those who need mechanical ventilation.

Fentanyl is an opioid analgesic that is 50-100 times more potent than morphine. It is used frequently because of its ability to provide rapid analgesia. A single dose of fentanyl significantly reduced pain behaviors and changes in heart rate. It also increased the growth hormone level.

Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with significant sedative and analgesic effects. Some studies have investigated its role in adult and pediatric intensive care, as a primary sedative or a second line following failure of benzodiazepines or opioid sedation, as a bridge for extubation, for substance withdrawal, and to decrease intensive care unit (ICU) delirium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Weaning eligibility

    Time frame: 48 hours postoperatively

    The time from ventilator weaning eligibility was monitored until discharge.

Secondary outcomes

  1. Time from eligibility to extubation

    Time frame: 60 min postoperatively

    Time from eligibility to extubation was monitored until discharge.

  2. Mean arterial pressure

    Time frame: 48 hours post-infusion initiation

    Mean arterial pressure was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation.

  3. Heart rate

    Time frame: 48 hours post-infusion initiation

    Heart rate was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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