Hydroxyzine Versus Triclofos for Sedation for Electroencephalography Recording in Children: A Noninferiority
Narmadham K Bharathi1, Sangeetha Yoganathan1, Maya Thomas1
1Paediatric Neurology Unit, Department of Neurological Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
Insights
Hydroxyzine is a safe and effective alternative to triclofos for sedating children during electroencephalography (EEG) recordings. While triclofos showed slightly higher success rates, hydroxyzine demonstrated comparable safety and efficacy for pediatric EEG sedation.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Neurophysiology
Background:
- Triclofos is a standard sedative for pediatric electroencephalography (EEG).
- There is a need for alternative sedative agents for pediatric EEG.
- Hydroxyzine is being evaluated as a potential alternative.
Purpose of the Study:
- To assess the efficacy, safety, and acceptability of hydroxyzine versus triclofos for pediatric EEG sedation.
- To determine if hydroxyzine is a noninferior alternative to triclofos.
Main Methods:
- A noninferiority randomized controlled trial compared hydroxyzine and triclofos in children aged six months to five years.
- Primary outcome: successful EEG completion (≥40 minutes sleep record in one hour).
- Secondary outcomes: sedation quality, adverse events, satisfaction, and EEG quality metrics.
Main Results:
- Successful EEG completion was 82.6% with hydroxyzine and 90.2% with triclofos (P=0.092).
- Time to sedation, need for additional sedatives, and adverse event profiles were comparable.
- Neurologist assessment of motion artifacts and EEG background rhythm were similar between groups.
Conclusions:
- Hydroxyzine appears to be a safe, acceptable, and efficacious alternative sedative for pediatric EEG.
- Further research may confirm its noninferiority and widespread clinical utility.
Background:
Triclofos is commonly used for sedation in children for electroencephalography (EEG) recording. A noninferiority randomized controlled trial was conducted to assess the efficacy, safety, and acceptability of hydroxyzine as an alternate drug for sedation.
Methods:
Children aged six months to five years who did not sleep naturally for EEG recording were randomly assigned to receive either hydroxyzine or triclofos in 1:1 ratio. Our primary outcome was successful EEG completion as defined by achieving at least 40 minutes of sleep record in a one-hour EEG recording. Our secondary outcomes were Ramsay sedation score, time taken for sedation, need for second dose of sedative agent, yield of abnormal EEG records, incidence of adverse events, technologist and caregiver satisfaction score (based on a Likert scale), neurologist assessment of motion artifacts based on a visual analog scale, and effect of the drug on the amplitude and frequency of the background rhythm. The parents were interviewed telephonically regarding any adverse effects within the next 24 hours.
Results:
Successful EEG completion was achieved in 82.6% in the hydroxyzine arm and in 90.2% in the triclofos arm with a mean difference of -7.66 (95% confidence interval: -16.5 to 1.2, P = 0.092). Secondary outcomes such as time taken to sleep, need for second dose of sedation, yield of abnormal EEG records, adverse effect profile, neurologist grading of motion artifacts, and effect on background were comparable between both groups.
Conclusion:
Hydroxyzine may be a safe, acceptable, and efficacious alternative sedative agent for EEG recording in children.
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