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OpenTrials
Completed

NCT Number: NCT07148882

Pain Managment in Preterm Neonates

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.

Completed

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Key information

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ainshams Univercity

Cairo, Cairo Governorate, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%

Primary outcomes

  1. measure MDA level as an oxidative stress marker.

    Time frame: just before fentanyl introduction and half hour after

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Intranasal Versus Intravenous Fentanyl Effect on Oxidative Stress in Preterm Neonates

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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