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Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

NCT07190625 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-10-01

No results posted yet for this study

Summary

Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management.

Using intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.

Conditions

  • Procedural Pain

Interventions

DRUG

fentanyl intravenous

giving intravenous fentanyl

DRUG

Fentanyl intranasal using atomizer

giving intranasal fentanyl using nasal atomizer

DRUG

fentanyl intranasal direct

giving intranasal fentanyl directly into nostrils

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Passant Fahmy, M.Sc · Assisstant lecturer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-24
Primary Completion
2026-03-01
Completion
2026-06-01

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 NCT07190625 on ClinicalTrials.gov