| Title | Safety of methylphenidate following traumatic brain injury: Impact on vital signs and side-effects during inpatient rehabilitation. | | Author(s) | Willmott C, Ponsford J, Olver J, Ponsford M | | Institution | Psychology Department, , Building 17, Monash University. | | Source | J Rehabil Med 2009 Jun; 41(7):585-7. | | Abstract | OBJECTIVE: The aim of the present study was to evaluate the safety of methylphenidate administered during inpatient rehabilitation following traumatic brain injury.
METHODS: Forty inpatients with moderate-severe traumatic brain injury (mean 68.4 days post-injury) participated in a randomized, cross-over, double-blind, placebo-controlled trial of methylphenidate administered at a dose of 0.3 mg/kg body weight twice daily.
RESULTS: Methylphenidate administration resulted in a statistically significant increase in pulse of 12.3 beats/min (95% confidence interval (CI) 9.25-15.36), diastolic blood pressure of 4.1 mmHg (95% CI 2.11-6.10), and mean arterial pressure of 3.75 mmHg (95% CI 1.79-5.72). These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate. Blinding was successful. Significantly greater reporting of irritability of 0.14 points (95% CI 0.02-0.26), difficulty sleeping of 0.17 points (95% CI 0.02-0.31) and total side-effects of 0.68 points (95% CI 0.06-1.30) was associated with methylphenidate compared with placebo.
CONCLUSION: Methylphenidate given at 0.3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase. This trial is registered with the Australian New Zealand Clinical Trials Registry (12607000503426). | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 19543672 |
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