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

Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of 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

Study Overview

• Status: Completed
• Conditions: Analgesia; Sedation and Analgesia; Neonatal; Mechanical Ventilation in Neonates
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: fentanyl 0.5 mcg/kg/hr; Drug: fentanyl 1mcg/kg/hr

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine and fentanyl; fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant 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	Drug: Dexmedetomidine; 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; Drug: fentanyl 0.5 mcg/kg/hr; fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant
Active Comparator: fentanyl only; fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24	Drug: fentanyl 1mcg/kg/hr; fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for additional rescue analgesia	number of doses of rescue analgesia given during the first 24 hours	24 hours
NPASS ( neonatal pain , agitation and sedation score)	done hourly to indicate pain and sedation if more than or equal to three patient is in pain	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of bradycardia,	development of bradycardia,	24 hours
development of hypotension	development of hypotension	24 hours
development of respiratory depression	development of respiratory depression	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: mariam JA ibrahim, PHD, Ain Shams University; Principal Investigator: Rouzan A Nassar, MBBCH, MOHP Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: adjuvant; dexmedetomidine; fentanyl; sedation; analgesia; full term neonates
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Piperidines; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: Dexmedetomidine as an Adjunct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data can be shared from the corresponding author upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No