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Completed

NCT Number: NCT07241351

Dexmedetomidine as an Adjunct to Fentanyl for Term Neonates on Mechanical Ventilation

Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation.

In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine

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Key information

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion.

In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Full term neonates (≥ 37 weeks gestational age)
  • Age: 1 to 28 days.
  • Neonates just started invasive mechanical ventilation and are going to start sedation.

Exclusion criteria

  • Presence of central nervous system abnormality
  • Complex multiple congenital anomalies
  • Neonates with facial malformations
  • Neonates on mechanical Ventilation setting (peep above 9)

Treatment and study plan

Dexmedetomidine

Drug

administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age

fentanyl 1mcg/kg/hr

Drug

fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours

fentanyl 0.5 mcg/kg/hr

Drug

fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant

Primary outcomes

  1. need for additional rescue analgesia

    Time frame: 24 hours

    number of doses of rescue analgesia given during the first 24 hours

  2. NPASS ( neonatal pain , agitation and sedation score)

    Time frame: 24 hours

    done hourly to indicate pain and sedation if more than or equal to three patient is in pain

Secondary outcomes

  1. development of bradycardia,

    Time frame: 24 hours

    development of bradycardia,

  2. development of hypotension

    Time frame: 24 hours

    development of hypotension

  3. development of respiratory depression

    Time frame: 24 hours

    development of respiratory depression

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Dec 2, 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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