Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

NCT07190625 | Recruiting Early Phase 1

• 1 other identifier: FMASU MD342/2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• procedural pain managment

  The efficacy of different modalities of intranasal fentanyl, either nasal atomizer or direct method, versus intravenous administration in neonatal pain management using Premature Infant Pain Profile (PIPP) scale before and after the administration. PIPP score ranges from 0 to 21, A PIPP score of 0-6 suggests minimal or no pain, 7-12 indicates moderate pain and a score ≥ 13 is interpreted as severe pain.

  from giving the fentanyl before the procedure till one hour after .

Study Arms (3)

intravenous group

ACTIVE COMPARATOR

this group of neonates will recieve intravenous fentanyl during procedure

Drug: fentanyl intravenous

direct intranasal group

ACTIVE COMPARATOR

this group of neonates will recieve direct intranasal fentanyl during procedure

Drug: fentanyl intranasal direct

nasal atomizer group

ACTIVE COMPARATOR

this group of neonates will recieve intranasal fentanyl with atomizer during procedure

Drug: Fentanyl intranasal using atomizer

Interventions

fentanyl intravenous DRUG

giving intravenous fentanyl

intravenous group

Fentanyl intranasal using atomizer DRUG

giving intranasal fentanyl using nasal atomizer

nasal atomizer group

fentanyl intranasal direct DRUG

giving intranasal fentanyl directly into nostrils

direct intranasal group

Eligibility Criteria

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

You may qualify if:

• Preterm neonates with gestational age between 28 and 36 weeks gestation.
• Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture.

You may not qualify if:

• known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.
• Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)
• Post-surgical patients.
• Patients sedated by fentanyl infusion / midazolam infusion.
• Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Passant Fahmy, M.Sc

  Assisstant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Passant Osama Fahmy, M.Sc

CONTACT

01066724641; Passant.Osama@med.asu.edu.eg

Rabab Gameel Allam, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 24, 2025
• Study Start: December 24, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-08

Locations

EG (1)