Pain Managment in Preterm Neonates

NCT07148882 | Completed Phase 2 DMC

• 1 other identifier: MS683/2023
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of Intranasal versus Intravenous Fentanyl on oxidative stress by measuring MDA level just before and after 30 minutes from painful procedure and comparing the results.

Conditions

Preterm Neonates Pain Managment; PreTerm Neonate

Outcome Measures

Primary Outcomes (1)

• measure MDA level as an oxidative stress marker.

  just before fentanyl introduction and half hour after

Study Arms (2)

intravenous fentanyl

ACTIVE COMPARATOR

Intravenous fentanyl group: will receive intravenous fentanyl(1 µg/kg/dose) and typically, one dose is givenMeasure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure

Drug: fentanyl

intranasal fentanyl

ACTIVE COMPARATOR

Intra nasal fentanyl group: will receive intranasal fentanyl (@fentanyl hamein 50mic/1ml, manufactured by sunny pharmaceutical) using nasal dose of INF is 1.5µg/kg/dose, and typically, one dose is given (Kaushal et al., 2020). Measure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure

Drug: fentanyl

Interventions

fentanyl DRUG

Intra nasal fentanyl group: will receive intranasal fentanyl using nasal dose of INF is 1.5µg/kg/dose, and typically one dose is given After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure). Intravenous fentanyl group: will receive intravenous fentanyl 1 µg/kg/dose and typically, one dose is given After 5minutes, a second dose could be administrated based on the clinical assessment maximum two doses per procedure. Measure MDA Malondialdehyde level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure. Monitor adverse events after fentanyl use as apnea cessation of breathing for \>20 s, bradycardia heart rate \< 100 beats/minute, desaturation oxygen saturation \< 80%

intranasal fentanyl; intravenous fentanyl

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Contraindication of nasal administration of drugs as bilateral occluded nasal passage as choanal atresia and Epistaxis.
• Surgical patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams Univercity

Cairo, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: August 29, 2025
• Study Start: February 1, 2024
• Primary Completion: September 10, 2024
• Study Completion: October 1, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-02

Locations

EG (1)