NCT05758090 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lim BG
Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J
The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-006
Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG
The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospecti
Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J
Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019

Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia

Details for clinical trial NCT05758090

Clinical trial NCT05758090 - References