Safety of methylphenidate following traumatic brain injury: Impact on vital signs and side-effects during inpatient rehabilitation
Year: 2009
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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 These changes did not, however, appear to be symptomatic, as no participants were withdrawn due to adverse events, and there was no significant self-report of increased heart rate with methylphenidate.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).
Authors: C Willmott, J Ponsford, J Olver, M Ponsford
Institutions: Monash University, Epworth Hospital
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,887
OpenAlex ID: W1999899687