Mary A McMahon1, Jilda N Vargus-Adams, Linda J Michaud, Judy Bean. 1. Division of Pediatric Rehabilitation, Department of Physical Medicine and Rehabilitation, University of Cincinnati School of Medicine and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Abstract
OBJECTIVE: To conduct a pilot study of amantadine in children with impaired consciousness caused by acquired brain injury, to establish design feasibility, and to assess the effect on level of arousal and consciousness. DESIGN: Randomized, double-blind, placebo-controlled crossover trial. Seven subjects (mean age, 12.7 yrs) with an acquired brain injury (mean duration, 6 wks) were randomized to receive either 3 wks of placebo or amantadine, followed by a 1-wk washout period and then 3 wks of the other agent. Main outcome measures were the Coma/Near-Coma Scale and Coma Recovery Scale-Revised, each done three times per week. Subjective evaluations of change in arousal and consciousness by the parent and physician were done weekly. RESULTS: Five subjects completed the study. There was no significant difference in the slopes of recovery during either arm for the Coma/Near-Coma Scale (P = 0.24) or the Coma Recovery Scale-Revised (P = 0.28), although improvements in consciousness were noted by the physician during weeks when amantadine was given (P = 0.02). CONCLUSIONS: This study suggests that amantadine facilitates recovery of consciousness in pediatric acquired brain injury and provides important information necessary to design future more definitive studies.
RCT Entities:
OBJECTIVE: To conduct a pilot study of amantadine in children with impaired consciousness caused by acquired brain injury, to establish design feasibility, and to assess the effect on level of arousal and consciousness. DESIGN: Randomized, double-blind, placebo-controlled crossover trial. Seven subjects (mean age, 12.7 yrs) with an acquired brain injury (mean duration, 6 wks) were randomized to receive either 3 wks of placebo or amantadine, followed by a 1-wk washout period and then 3 wks of the other agent. Main outcome measures were the Coma/Near-Coma Scale and Coma Recovery Scale-Revised, each done three times per week. Subjective evaluations of change in arousal and consciousness by the parent and physician were done weekly. RESULTS: Five subjects completed the study. There was no significant difference in the slopes of recovery during either arm for the Coma/Near-Coma Scale (P = 0.24) or the Coma Recovery Scale-Revised (P = 0.28), although improvements in consciousness were noted by the physician during weeks when amantadine was given (P = 0.02). CONCLUSIONS: This study suggests that amantadine facilitates recovery of consciousness in pediatric acquired brain injury and provides important information necessary to design future more definitive studies.
Authors: Rim M Hadgu; Amne Borghol; Christopher Gillard; Candice Wilson; Suzan Elqess Mossa; Megan McKay; Charles Jastram; Ifeanyi O Onor Journal: Hosp Pharm Date: 2020-05-17
Authors: Matthew J McLaughlin; Eric Caliendo; Ryan Lowder; William D Watson; Brad Kurowski; Katherine T Baum; Laura S Blackwell; Christine H Koterba; Kristen R Hoskinson; Sarah J Tlustos; Kanecia O Zimmerman; Sudhin A Shah; Stacy J Suskauer Journal: J Head Trauma Rehabil Date: 2021-07-26 Impact factor: 3.117