Ainshams Univercity
Cairo, Cairo Governorate, 02, Egypt
NCT Number: NCT07148882
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.
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Notify Me1 hour–28 day
All sexes
Interventional
Phase 2 / Phase 3
Cairo, Cairo Governorate, 02, Egypt
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• Preterm neonates during endotracheal intubation
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Exclusion criteria
o Contraindication of fentanyl use as hypersensitivity.
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%
Time frame: just before fentanyl introduction and half hour after
Ain Shams University
Other
Intranasal Versus Intravenous Fentanyl Effect on Oxidative Stress in Preterm Neonates
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