Accrual Suspensions in Seamless Phase II/III Trials: A Review of NRG Oncology Trials.

Purpose: A phase II/III trial is a type of phase III trial that has embedded in it an intermediate phase II go/no-go decision as to whether to continue the accrual to the phase III sample size. We examine the design characteristics and experience of a well-defined set of National Cancer Institute phase II/III trials, with special emphasis on designed accrual suspensions while awaiting the data to become mature enough for the phase II analysis. This experience is used to highlight the potential of using a calendar backstop to avoid an inordinately long accrual suspension.

Repeated, High-dose Fentanyl Administration in Rats Reveals Minimal Tolerance to Unconsciousness, Bradycardia, Muscle Rigidity and Respiratory Depression.

Background: Fentanyl is a synthetic opioid that is widely used in anesthesiology, but its illicit use is rapidly increasing. At high doses fentanyl induces unconsciousness and muscle rigidity, the mechanisms of which are poorly understood. Since animal models are needed to study these effects, the aim of this study was to establish a rat model of fentanyl abuse and investigate the effects of repeated high-dose fentanyl injections on loss of righting reflex, heart rate, respiratory depression, muscle, and brain activity.

Intraoperative Non-Opiate Anesthesia for Patients Undergoing Arthroscopic Temporomandibular Joint Surgery: A Randomized Controlled Trial.

Background: Pain intensity after temporomandibular joint (TMJ) surgery is often underestimated, and inadequate pain control may relate to poor recovery quality, increased opioid consumption, and longer hospital stay. This trial aims to evaluate whether non-opiate anesthesia provides a promising option of pain management for patients undergoing TMJ surgery.

Methods: Sixty patients receiving TMJ surgery were randomly assigned to either the control group or the non-opiate group.