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
Affiliation(s): Psychology Department, School of Psychology, Psychiatry & Psychological Medicine, Monash University, Clayton, VIC, Australia.
Publication date & source: 2009-06, J Rehabil Med., 41(7):585-7.
Publication type: Comparative Study; Randomized Controlled Trial
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 These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate.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).