Trials Sponsors Conditions Drugs Pricing

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 intravenousDrug

giving intravenous fentanyl

intravenous group

Fentanyl intranasal using atomizerDrug

giving intranasal fentanyl using nasal atomizer

nasal atomizer group

Eligibility Criteria

AgeUp to 28 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (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:

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological 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

Actual (reported)

Primary Completion

March 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

intravenous group

direct intranasal group

nasal atomizer group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

intravenous group

direct intranasal group

nasal atomizer group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations