PreTerm Neonate, Preterm Neonates Pain Managment
Conditions
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.
Interventions
DRUGfentanyl
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%
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measure MDA level as an oxidative stress marker. | just before fentanyl introduction and half hour after |
Countries
Egypt
Outcome results
None listed