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.

中文翻译：

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褪黑激素与三氯磷在小儿脑电图睡眠中的疗效和耐受性：一项单盲随机对照试验

目的

比较褪黑激素与三氯磷的功效（成功 EEG 的比例、需要增强、睡眠潜伏期 (SOL)、放电率、睡眠持续时间、伪影的存在和等级）和耐受性（不良反应概况）。

方法

进行了一项随机试验（区组随机化）。所有儿童都被告知睡眠剥夺，脑电图技术人员管理该药物。如果可以获得至少 30 分钟的记录（有或没有清醒状态的睡眠），则 EEG 被标记为成功。小儿神经科医生报告了脑电图结果 - 睡眠发作潜伏期、癫痫样异常并对伪影进行了分级（如果存在过度的 β 活动和运动伪影）。第二天，一位儿科住院医师通过电话对父母进行了采访，了解任何不良反应。父母、儿科神经病学家和儿科住院医师对所给予的药物不知情。

结果

228 名儿童被随机分配（每人 114 名接受褪黑激素和三氯磷）。两组在基线年龄组和人口统计数据方面具有可比性。脑电图成功的比例在褪黑激素中为 89.4%，在三氯氟磷中为 91.2%。褪黑激素组首剂有效率为 64%，三氯磷组为 63.15%。褪黑激素组 25.4% 和三氯氟磷组 28% 需要增加剂量。服用褪黑激素后平均总睡眠时间为 80 分钟，服用三氯磷后为 82.39 分钟。在 6.14% 的褪黑激素和 8.65% 的三氯磷组中观察到不良反应。没有一个结果具有统计学意义。

结论

Melatonin 和 Triclofos 的疗效和耐受性之间没有显着差异。褪黑激素可以安全地用于儿童脑电图的睡眠。