Fentanyl clinical study

Consistent with the preclinical pharmacological profile of DPI-3290, recent early clinical studies with this compound have indicated strong analgesic activity in man. These actions are dose dependent and rapid in onset, with less apparent adverse changes in saturated 02 or emesis when compared with equivalent analgesic doses of morphine or fentanyl. Patients appeared to tolerate doses of DPI-3290 well in these early studies with no dose-limiting adverse events. 

The donor solution pH and fentanyl concentration were very similar to the pH and concentration of the donor formulation used in the clinical study. 

Heintz-Bamberg D, Muller H, Dick W, Reiter G. Vergleichende Klinische Untersuchungen zum Verhalten hamodynamischer Parameter be kombinationsnarkosen mit Nalbuphin (Nubain) und Fentanyl. [Comparative clinical studies of the hemodynamic parameters by anesthesia combination with nalbuphine (Nubain) and fentanyl.] Anaesthesist 1987 36(5) 217-22. 

Clinical electrophysiological procedures can be very complex and prolonged, requiring safe and effective conscious sedation. A study in 700 patients has shown that intermittent midazolam plus fentanyl in electrophysiological procedures is safe and efficacious (3). All the staff were ACLS-certified and had successfully completed conscious sedation training courses, but none was an anesthetist one team member was dedicated to monitoring conscious sedation and providing rescue defibriUation if required. 

In a study in 12 healthy subjects, grapefruit juice had minimal effect on peak plasma levels or clinical effects of oral transmucosal fentanyl, despite a considerable proportion of the dose being swallowed and absorbed enterally. ... 

Comparative studies In a comparison of intravenous morphine 0.1 mg/kg and nebulized fentanyl 4 micrograms/kg in 77 children with clinically suspected limb fractures, fentanyl was better at controlling pain [134 =]. 

---