Melatonin and Triclofos Sodium to Execute Sleep Electroencephalography in Pediatric Patients: A Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial.

OBJECTIVES: To evaluate cost-effectiveness between oral sedatives melatonin and triclofos sodium used to perform sleep electroencephalography (EEG) in pediatric patients and develop a criterion for resource allocation by the institution. METHODS: This prospective study was conducted alongside the randomized controlled trial conducted at a tertiary care hospital, wherein pediatric patients arriving for sleep EEG were randomized to receive melatonin dosed at 0.3 mg/kg (< 10 kg), 3 mg (10-15 kg), and 6 mg (> 15 kg) and triclofos at 50 mg/kg (maximum dose 1 g, 6 mo to 11 y; 2 g, 11 to 18 y) after due consent. The cost-effectiveness analysis was performed from the healthcare institution's perspective. Successful EEG and abnormal EEG were the effectiveness parameters. RESULTS: Two hundred twenty-eight patients were divided equally between two groups. Melatonin (N = 114) and triclofos (N = 114) recorded successful EEG in 89.4% and 91.2% patients and abnormal EEG in 49% and 42.3% patients, respectively (p > 0.05). The total direct cost incurred was INR 1881.75 (USD 26.6) and INR 2772.5 (USD 39.2) for melatonin and triclofos, respectively (p < 0.05). The cost-effectiveness ratio-1 (CER-1) for melatonin and triclofos per successful EEG recorded was INR 18.45 (USD 0.39) and INR 26.66 (USD 0.58), respectively. The CER-2 for melatonin and triclofos per abnormal EEG detected was INR 37.64 (USD 0.53) and INR 63.01 (USD 0.89), respectively. CONCLUSIONS: Melatonin is more cost-effective than triclofos when charged based on individual dose requirements. Hospitals, diagnostic centers, healthcare institutions may consider resource-utilization-based costing system for cost-effective allocation of resources.

Efficacy and tolerability of Melatonin vs Triclofos to achieve sleep for pediatric electroencephalography: A single blinded randomized controlled trial.

PURPOSE: To compare Melatonin with Triclofos for efficacy (proportion of successful EEG, need of augmentation, sleep onset latency (SOL), yield of discharges, duration of sleep, presence and grade of artifacts) and tolerability (adverse effect profile). METHODS: A randomized trial was performed (block randomization). All children were advised regarding sleep deprivation, EEG technician administered the drug. EEG was labelled successful if at least 30 min of record could be obtained (sleep with or without awake state). Pediatric neurologist reported the EEG findings-sleep onset latency, epileptiform abnormalities and graded the artifacts (excess beta activity and movement artifacts if present). The parents were interviewed telephonically next day by a pediatric resident for any adverse effects. The parents, pediatric neurologist and pediatric resident were blinded for the drug given. RESULTS: 228 children were randomized (114 each received Melatonin and Triclofos). Both the groups were comparable at baseline for age group and demographic data. The proportion of successful EEG was 89.4% in Melatonin and 91.2% in Triclofos. First dose was effective in 64% in Melatonin and 63.15% in Triclofos group. Augmentation dose was needed in 25.4% in Melatonin and 28% in Triclofos group. Mean total sleep duration was 80 min after Melatonin and 82.39 after Triclofos administration. Adverse effects were observed in 6.14% of Melatonin and 8.65% of Triclofos group. None of the results were statistically significant. CONCLUSION: There was no significant difference between efficacy and tolerability of Melatonin and Triclofos. Melatonin can be safely used to achieve sleep for EEG in children.