Efficacy and safety of oral triclofos as sedative for children undergoing sleep electroencephalogram: An observational study.

OBJECTIVES: Triclofos may be a better sedative in view of better palatability and less gastric irritation as compared to chloral hydrate. This study aimed to assess the efficacy of triclofos (a commonly used sedative in India) as a sedative for sleep electroencephalogram (EEG) study in children.
METHODS: This prospective observational study was carried out in a tertiary care pediatric center. Consecutive children aged 6 months to 5 years referred for sleep EEG evaluation were recruited. Their clinical details were noted in a proforma after an informed consent. After a trial for natural sleep, oral triclofos was administered. Sleep parameters and adverse effects were noted.
RESULTS: One-hundred and sixty children were then enrolled. EEG was successfully recorded in 149 (93.1%) children. Median latency of sleep onset was 30 min and median duration of sleep was 90 min. The adverse effects in the following 24 h were mild and included dizziness, irritability, and vomiting.
CONCLUSIONS: Oral triclofos was found to be an effective sedative for EEG in children with minimal adverse effects.

Introduction

Triclofos is the monophosphate sodium salt of trichloroethanol (pharmacologically active metabolite of chloral hydrate).[1] One gram of triclofos sodium is equivalent to 600 mg of chloral hydrate. Triclofos may be a better sedative in view of better palatability and less gastric irritation as compared to chloral hydrate. This study aimed to assess the efficacy of triclofos as sedative for sleep electroencephalogram (EEG) study in children.

Methods

This prospective study was carried out in a tertiary care pediatric center in North India from October 2013 to March 2014. The consecutive children aged 6 months to 5 years referred for sleep EEG evaluation were recruited. Children with parents who failed to give consent and lacked telephonic facility (required for follow-up) were excluded. The study was approved from the Ethics Committee of the institute.

Prior to the day of EEG appointment, the parents were asked to keep their child nil per-oral for at least 4 h and awaken the child 2 h prior to the usual time of morning awakening on the day of EEG, if possible. On arrival in the EEG lab, the children were assessed for eligibility and an informed consent was taken from the enrolled children. Their clinical details were noted in a pro forma. Age, sex, and indication for EEG were recorded. The details of the anticonvulsant drugs (if applicable), associated developmental delay, duration of sleep in the last 24 h, and night time awakenings were recorded.

The child along with the parent was sent to a dark, quiet room for trial of natural sleep. If the sleep ensued, EEG recording was done for 30 min. If the child did not sleep after 60 min, he/she was given oral triclofos syrup (500 mg/5 ml) at the dose of 50 mg/kg. If the child did not sleep after 30 min, a second dose was administered [Figure 1]. If the child did not sleep after the second dose, the EEG was re-scheduled.

Figure 1

Flow of the study participants

After the EEG recording was completed, the child was monitored clinically till awakening by a trained staff member. Then, he/she was sent home. A telephonic enquiry was made after 24 h regarding any adverse effects (dizziness, irritability, and vomiting). The EEG findings were also noted. Presence of any diffuse beta activity was also recorded.

Descriptive statistics was used to analyze the data. STATA 9.0 (StataCorp, 4905 Lakeway Drive, College Station, Texas 77845, USA) was used for analysis.

Results

During the study period, 689 EEGs were done. Sleep EEG study was done in 184 (26.7%) children. Twenty-four children (13%) achieved spontaneous sleep. One-hundred and sixty children were then enrolled. None of them were excluded.

The baseline characteristics are described in Table 1. A majority of them had epilepsy-related indication (86.3%) and a majority of 73.1% were on anti-convulsant drugs.

Table 1

Baseline characteristics of the study population

One dose of triclofos was sufficient in 132 (82.5%) children; rest required a second dose. EEG was successfully recorded for 30 min in 149 (93.1%) children. Among children requiring single dose of triclofos, median latency of sleep onset was 30 min (inter-quartile range: 15–40) and median duration of sleep was 90 min (inter-quartile range: 60–120). The adverse effects in the following 24 h were mild and included dizziness (16), irritability (5), and vomiting (1). None of them required oxygen or airway manipulation.

The EEG findings are tabulated in Table 2. Only 9 children (5.6%) had diffuse beta activity on EEG.

Table 2

Electroencephalography findings in the study population

Discussion

An ideal sedative for sleep EEG in children may be the one which is easy to administer, has short sleep onset latency with acceptable duration of sleep, minimum adverse effects, and minimum effects on EEG. This study tried to explore these issues with regard to triclofos.

Oral triclofos is the most commonly used sedative for pediatric EEGs across India. It is cheap and easily available. However, the clinical experience with its use has rarely been reported.[1] It has also been used for preoperative sedation[2] and dental procedures.[3]

Millichap[1] randomized 71 children to receive either oral triclofos or chloral hydrate for sleep EEG sedation. The mean sleep onset latencies were 37.3 ± 12.1 min and 36.6 ± 14.4 min for triclofos and chloral hydrate, respectively (P > 0.05). Side effects described included ataxia, dizziness, drowsiness, obtundation, hyperactivity, and incoordination (around one-fourth of children in each group). Fifty-seven percent children in triclofos group and 41% children in chloral hydrate group like the taste of the drug.

In our study population, median sleep onset latency was 30 min with acceptable median sleep duration (90 min). Majority of the children (93.1%) had successful EEG recording. The adverse effects were mild, not requiring any medical therapy.

Only 5.6% of the children showed diffuse beta activity on EEG. In contrast, benzodiazepines have been commonly shown to increase beta activity and cause diffuse background slowing.[4]

Besides triclofos and chloral hydrate, hydroxyzine (long-acting first generation H1 antagonist),[56] oral midazolam,[7] and melatonin (pineal hormone regulating the sleep wake cycle)[8] have been used recently. Their results have been summarized in Table 3.

Table 3

Summary of studies exploring various sedatives for sleep electroencephalography in children

Conclusion

Oral triclofos was found to be an effective sedative for EEG in children with minimal adverse effects. More detailed studies are required to explore the effects of triclofos on EEG in comparison with the recently used sedatives with regard to safety and efficacy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.