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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous fentanyl | Active Comparator | 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 |
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| intranasal fentanyl | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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% |
| Measure | Description | Time Frame |
|---|---|---|
| measure MDA level as an oxidative stress marker. | just before fentanyl introduction and half hour after |
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Inclusion Criteria:• Preterm neonates during endotracheal intubation
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Exclusion Criteria:o Contraindication of fentanyl use as hypersensitivity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams Univercity | Cairo | Cairo Governorate | 02 | Egypt |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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