Dexmedetomidine Intranasal for Heart Disease (DexPK Trial)

"Given that this is only a Phase 1 trial, there is limited data supporting the efficacy and safety of Dexmedetomidine Intranasal. Our team has given it a score of 1."

"From what is detailed on clinicaltrials.gov, it appears that this trial is still looking for patients to enrol. The original posting date was 8/20/2018, with the most recent update on 3/7/2022."

"This particular clinical trial is enrolling 18 young patients that have been diagnosed with a heart condition. These patients must be between 6 months and 4 years old to qualify. To receive Dex as part of this study, the attending cardiac anesthesiologists must determine that the child is a good candidate for the trial and that the child's parent or guardian has given written consent."

"According to the rules set out for this trial, the minimum age a patient can be is 6 months old whereas the maximum age is 48 months old."

"The objective of this study, as indicated by blood samples drawn at specific intervals, is to compare maximum blood concentration levels of Dex between intranasal and intravenous administration. Additionally, the bioavailability of intranasal Dex relative to intravenous Dex will be analyzed for both distribution and elimination. Data will be collected for approximately one half-life of Dex, allowing for estimation of the relative bioavailability of intranasal vs intravenous Dex. Adverse events will be monitored by measuring heart rate, and investigators will also be looking for any changes in vital signs."

"Currently, Dexmedetomidine Intranasal is being trialed in 119 separate clinical studies, with the majority of those in their third phase. The largest number of these trials are based in Karachi, Sindh, but there are a total of 221 locations running these trials."

"Dexmedetomidine Intranasal is a medication with a variety of uses, including treating disease, ventilations, mechanical, cyclic vomiting syndrome, and intubations."