drugset / Trial / NCT03718507
Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants
RandomizedParallel-groupOpen-labelSupportive care
Summary
Given the popularity that LISA technique has gainig in worldwide neonatal units, the lack of evidence regarding its premedication is becoming even more relevant to provide the best care to premature infants. Objective of this clinical trial is to establish the best premedication for LISA procedure considering neonatal pain assessed with premature infants pain scale, salivary cortisol levels as an indicator of stress and crSO2 values as indicators of cerebral oxygenation. Moreover, we aim to verify if sucrose 24% given orally is an effective tool for pain management in preterm neonates also in more invasive procedure, comparable to pharmacological treatment.
Timeline
- Start
- 2019-05-20
- Primary completion
- 2019-12-20
- Completion
- 2020-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 0.5 ug/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 2 ug/kg | Intravenous |
| Subject | Sucrose | Small molecule | 0.5 ml | Oral |
| Background | Atropine | Other / unclassified | 0.01 mg/kg | Intravenous |
| Background | Atropine | Other / unclassified | 0.02 mg/kg | Intravenous |