2 results match your criteria: "Post Approval Clinical Development[Affiliation]"
A randomized, double-blind, dose-controlled study of the use of dexmedetomidine alone for procedural sedation of children and adolescents undergoing MRI scans.
Paediatr Anaesth
May 2024
Post Approval Clinical Development, Pfizer, Inc., New York, New York, USA.
Article Synopsis
- Dexmedetomidine is a medication used for sedation, initially approved for adults in hospitals and now also used off-label for children during procedures like MRI.
- A study was conducted to assess the safety and effectiveness of dexmedetomidine in children aged 1 month to 17 years, examining various dosages to see how many could complete an MRI without needing extra anesthesia.
- Results showed that a higher dose of dexmedetomidine significantly increased the number of children who completed the MRI without needing additional sedation, with some mild adverse effects observed.
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application.
Ther Innov Regul Sci
January 2023
Pfizer Inc., Groton, CT, USA.
Introduction: This project aimed to retrospectively obtain, review, and extract key safety data from medical records of participants enrolled in RAMPART, the NIH-supported Rapid Anticonvulsant Medication Prior to ARrival Trial of intramuscular midazolam versus intravenous lorazepam for pre-hospital treatment of status epilepticus, to support a US new drug application (NDA) for intramuscular midazolam.
Methods: A collaborative partnership was established between the NDA sponsor, the RAMPART trial lead academic institution, US government agencies, and contract research organizations to retrieve, review, and extract relevant safety data from the medical records of RAMPART participants and summarize those data to include in an NDA submitted to the US Food and Drug Administration (FDA).
Results: Key data in the medical records of 890 RAMPART trial participants (1020 enrollments, including 130 repeat enrollments) were reviewed and extracted into a project database.