Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
52 participants
INTERVENTIONAL
2024-02-01
2024-10-01
Brief Summary
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Detailed Description
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• 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intravenous 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
fentanyl
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%
intranasal 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
fentanyl
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%
Interventions
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fentanyl
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%
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Surgical patients.
1 Hour
28 Days
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ainshams Univercity
Cairo, Cairo Governorate, Egypt
Countries
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Other Identifiers
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MS683/2023
Identifier Type: -
Identifier Source: org_study_id