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Table 14.5 Dopaminergic Agents for the Acute Management of Pediatric TBI

Author Year Country

Study Design

Sample Size

Methods Outcomes

McMahon et al.

(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).

 

Vargus-Adams et al.

(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).

Patrick et al.

(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).