Pain Managment in Preterm Neonates

Not Applicable

Completed

• Conditions: Preterm Neonates Pain Managment; PreTerm Neonate
• Interventions: Drug: fentanyl

• Registration Number: NCT07148882
• Lead Sponsor: Ain Shams University

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.

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.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-09-10
• Study Completion: 2024-10-01
• Status Verified: 2025-02
• Study First Submitted: 2025-08-23
• Study First Submitted QC: 2025-08-23
• Last Update Submitted: 2025-08-23
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Preterm neonates during endotracheal intubation

-

Exclusion Criteria

o Contraindication of fentanyl use as hypersensitivity.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous fentanyl	fentanyl	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
intranasal fentanyl	fentanyl	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

Primary Outcome Measures

Name	Time	Method
measure MDA level as an oxidative stress marker.	just before fentanyl introduction and half hour after

Trial Locations

Locations (1)

Ainshams Univercity; 🇪🇬 Cairo, Cairo Governorate, Egypt