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

NCT07241351 | Completed Phase 2

• 1 other identifier: Dexmedetomidine as an Adjunct
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia; Sedation and Analgesia; Neonatal; Mechanical Ventilation in Neonates

Keywords

sedation; analgesia; full term neonates; dexmedetomidine; fentanyl; adjuvant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• development of bradycardia,

  24 hours

• development of hypotension

  24 hours

• development of respiratory depression

  24 hours

Study Arms (2)

dexmedetomidine and fentanyl

EXPERIMENTAL

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; Drug: fentanyl 0.5 mcg/kg/hr

fentanyl only

ACTIVE COMPARATOR

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

Drug: fentanyl 1mcg/kg/hr

Interventions

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

dexmedetomidine and fentanyl

fentanyl 1mcg/kg/hr DRUG

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

fentanyl only

fentanyl 0.5 mcg/kg/hr DRUG

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

dexmedetomidine and fentanyl

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• mariam JA ibrahim, PHD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Rouzan A Nassar, MBBCH

  MOHP Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)