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.
Keywords: Electroencephalography; Hydroxyzine; Noninferiority; Randomized controlled trial; Sedation; Triclofos.
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