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A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children
Marie Christy Sharafine Stephen1, John Mathew2, Ajoy Mathew Varghese2
1Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India sharafine@gmail.com.
Insights
Chloral hydrate syrup and intranasal midazolam are safe for pediatric procedural sedation. Chloral hydrate demonstrated superior efficacy, with faster sedation onset and recovery, and higher satisfaction rates compared to intranasal midazolam.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Clinical Trial Research
Background:
- Procedural sedation in children is crucial for diagnostic tests like auditory brainstem response.
- Intranasal midazolam and chloral hydrate are commonly used agents for pediatric procedural sedation.
- Comparative efficacy and safety data are essential for optimal clinical decision-making.
Purpose of the Study:
- To compare the efficacy and safety of intranasal midazolam versus chloral hydrate syrup for procedural sedation in children undergoing auditory brainstem response testing.
- To evaluate secondary outcomes including onset of sedation, recovery time, and satisfaction levels.
Main Methods:
- A prospective, randomized, double-blind, double-dummy, placebo-controlled trial was conducted.
- Eighty-two children (1-6 years) received either intranasal midazolam (0.5 mg/kg) or chloral hydrate syrup (50 mg/kg).
- Primary outcomes were safety and efficacy; secondary outcomes included time to sedation onset, recovery, and satisfaction.
Main Results:
- No major adverse events were reported in either group.
- Chloral hydrate showed significantly earlier sedation onset (66% vs. 33%) and faster recovery (78 min vs. 108 min) compared to intranasal midazolam.
- Overall sedation success was higher with chloral hydrate (95%) than intranasal midazolam (51%), with greater parent and audiologist satisfaction.
Conclusions:
- Both intranasal midazolam and chloral hydrate are safe and effective for pediatric procedural sedation.
- Chloral hydrate syrup is superior to intranasal midazolam, offering faster onset, quicker recovery, and improved satisfaction.
- Chloral hydrate is a preferred agent for procedural sedation in this pediatric population.
Objectives:
To evaluate the efficacy and safety of intranasal midazolam and chloral hydrate syrup for procedural sedation in children.
Study Design:
Prospective randomized placebo-controlled trial (double blind, double dummy).
Setting:
Tertiary care hospital over 18 months.
Subjects And Methods:
Eighty-two children, 1 to 6 years old, undergoing auditory brainstem response testing were randomized to receive either intranasal midazolam with oral placebo or chloral hydrate syrup with placebo nasal spray. Intranasal midazolam was delivered at 0.5 mg/kg (100 mcg per spray) and oral syrup at 50 mg/kg. Children not sedated at 30 minutes had a second dose at half the initial dose. The primary outcomes measured were safety and efficacy. Secondary outcomes were time to onset of sedation, parental separation, nature of parental separation, parental satisfaction, audiologist's satisfaction, time to recovery, and number of attempts.
Results:
Forty-one children were in each group, and no major adverse events were noted. The chloral hydrate group showed earlier onset of sedation (66%) compared with the intranasal midazolam group (33%). Significant difference in time to recovery was noted in the chloral hydrate group (78 minutes) versus the intranasal midazolam group (108 minutes). The parents' and audiologist's satisfaction was higher for chloral hydrate (95% and 75%) than for intranasal midazolam (49% and 29%, respectively). Overall, sedation was 95% with chloral hydrate versus 51% with intranasal midazolam. Both drugs maintained sedation.
Conclusions:
Intranasal midazolam and chloral hydrate are both safe and efficacious for pediatric procedural sedation. Chloral hydrate was superior to intranasal midazolam, with an earlier time to onset of sedation, a faster recovery, better satisfaction among parents and the audiologist, and successful sedation.
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