Safety of methylphenidate following traumatic brain injury: Impact on vital signs and side-effects during inpatient rehabilitation
Catherine Willmott, Jennie Ponsford, John Olver, Michael Ponsford
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 These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate.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).
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