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

NCT07241351 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

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 1mcg/kg/hr

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

DRUG

fentanyl 0.5 mcg/kg/hr

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • mariam JA ibrahim, PHD · Ain Shams University

  • Rouzan A Nassar, MBBCH · MOHP Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-11-01
Completion
2025-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07241351 on ClinicalTrials.gov