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Pain Managment in Preterm Neonates

NCT07148882 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

DRUG

fentanyl

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%

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-09-10
Completion
2024-10-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT07148882 on ClinicalTrials.gov