NCT07148882

Pain Managment in Preterm Neonates

Intranasal Versus Intravenous Fentanyl Effect on Oxidative Stress in Preterm Neonates

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Accepted

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.

Detailed description

1. 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) 2. 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%), and chest wall rigidity associated with laryngospasm (Pacifici, 2015) for 60 min after IN fentanyl administration.

Conditions

• Preterm Neonates Pain Managment
• PreTerm Neonate

Interventions

Type	Name	Description
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%

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-09-10
• Completion: 2024-10-01
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: Egypt