Table 14.5 Dopaminergic Agents for the Acute Management of Pediatric TBI
Author Year Country Study Design Sample Size |
Methods | Outcomes |
(2009) USA RCT PEDro=6 NInitial=7, NFinal=6 |
Population: ABI: TBI=5, Stroke=1, Anoxia=1; Mean Age=12.7yr; Gender: Male=6, Female=1; Mean Time Post Injury=6.7wk; Mean GCS=4. Intervention: Patients were randomized to receive either 4 mg/kg body weight of amantadine for 1wk followed by 6 mg/kg body weight for 2wk or a placebo. After a 1wk washout period, the patients were crossed over and treated for another 3 wk. Assessments were conducted up to 3 x/wk. Outcome Measure: Coma/Near-Coma Scale (CNCS), Coma Recovery Scale Revised (CRS-R), Sleep Scale, Wee-FIM, Physician Evaluation, Parents’ Evaluation. |
1. There were no significant differences in recovery between amantadine and placebo according to CNCS, CRS-R or Wee-FIM scores (p=0.240, p=0.280, p=0.330 respectively). 2. Physician’s evaluations revealed significantly greater improvements in consciousness (p=0.020) but not for changes in arousal (p=0.170). 3. Parent’s evaluations did not reveal any significant differences in consciousness or arousal (p=0.500, p=0.120 respectively). |
(2010) USA A secondary analysis of McMahon et al. (2009) |
Population: ABI: TBI=5, Stroke=1, Anoxia=1; Mean Age=12.7yr; Gender: Male=6, Female=1; Mean Time Post Injury=6.7wk; Mean GCS=4. Intervention: A secondary analysis to determine the pharmacokinetic properties of amantadine in children. Outcome Measure: Coma/Near-Coma Scale (CNCS), Coma Recovery Scale Revised (CRS-R), Sleep Scale. |
1. A significant correlation was reported between CRS-R and maximum concentration of Amantadine (p=0.010), however, scatterplots did not reveal any observable relationship. 2. One significant association was found between CSR-R scores and average concentration of Amantadine (p=0.010). Other associations between CNCS (p=0.38, p=0.39, p=0.79) or CRS-R scores (p=0.06, p=0.11) and average concentration of Amantadine were not significant. However, the only significant CRS-R score did not reveal any relationship on the scatterplot. 3. Sleep Scale mean scores for nights on Amantadine and placebo were not found to be significantly different (p=0.20). |
(2003) USA Case Series N=10 |
Population: ABI: TBI=7, Encephalopathy=2, Stroke=1; Mean Age=13.7yr; Gender: Male=7, Female=3; Mean Time Post Injury=52.5 d; Mean GCS=3.1. Intervention: A retrospective review of patients who had been treated with dopamine agonists (amantadine, pramipexole, bromocriptine, levodopa, methylphenidate) for a mean of 39d was conducted. Assessments were performed at 15, 26 and 43d on average following onset of treatment. Outcome Measure: Western NeuroSensory Stimulation Profile (WNSSP). |
1. Patients demonstrated significant improvement on WNSSP scores from baseline to final assessment (p=0.020) with overall mean score also significantly differing from baseline (p<0.010). 2. The rate of change for WNSSP scores was 1.11 points greater per day during the treatment phase compared to the pre-medication phase (p=0.020). |