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| Name | Class |
|---|---|
| Albert B. Sabin Vaccine Institute | OTHER |
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In newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F | Active Comparator | Patients that received continued infusion of fentanyl at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop |
|
| T | Experimental | Patients that received continued infusion of tramadol at a steady dose for the first 48 hours and, then, doses were gradually decreases until stop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FentanyL | Drug | Fentanyl: 1 µg/kg/h for preterm infants and 2 µg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment wuth CRIES and NFCS pain scales during the first 72 hours after surgical procedure | Every 2-4h during the first 72 hours after surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time between surgical procedure and successful extubation | Hospital stay | |
| Time between surgical procedure and achievement of 100 mL/kg of enteral feeding | hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Guinsburg, MD | Federal University of São Paulo | Study Director |
| Ana Julia C Alencar | Federal university of são Paulo and Albert Sabin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Sabin Hospital | Fortaleza | Ceará | 60.410.790 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21471025 | Derived | Alencar AJ, Sanudo A, Sampaio VM, Gois RP, Benevides FA, Guinsburg R. Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F24-9. doi: 10.1136/adc.2010.203851. Epub 2011 Apr 5. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
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| Tramadol | Drug | Tramadol: 0.1 mg/kg/h for preterm infants and 0.2 mg/kg/h for term infants for 48 hours and than gradually decrease until interruption of the drug. |
|
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000441 |
| Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |