A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children.
OBJECTIVE
To evaluate the efficacy and safety of intranasal midazolam and chloral hydrate syrup for procedural sedation in children.


METHODS
Prospective randomized placebo-controlled trial (double blind, double dummy).


METHODS
Tertiary care hospital over 18 months.


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.
Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India sharafine@gmail.com.
Marie Christy Sharafine
MC
Stephen
Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.
John
J
Mathew
Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.
Ajoy Mathew
AM
Varghese
Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.
Mary
M
Kurien
Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.
George Ani
GA
Mathew
D000281:Administration, Intranasal; D002675:Child, Preschool; D002697:Chloral Hydrate / Q000008:administration & dosage*; D016292:Procedural Sedation; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D010100:Oxygen / Q000097:blood; D056152:Respiratory Rate / Q000187:drug effects
D006993:Hypnotics and Sedatives; D002697:Chloral Hydrate; D008874:Midazolam; D010100:Oxygen
auditory brainstem response audiometry; chloral hydrate; midazolam; sedation