Tags

Type your tag names separated by a space and hit enter

A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children.
Otolaryngol Head Neck Surg 2015; 153(6):1042-50OH

Abstract

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.

Authors+Show Affiliations

Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India sharafine@gmail.com.Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26286872

Citation

Stephen, Marie Christy Sharafine, et al. "A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children." Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, vol. 153, no. 6, 2015, pp. 1042-50.
Stephen MC, Mathew J, Varghese AM, et al. A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children. Otolaryngol Head Neck Surg. 2015;153(6):1042-50.
Stephen, M. C., Mathew, J., Varghese, A. M., Kurien, M., & Mathew, G. A. (2015). A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children. Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 153(6), pp. 1042-50. doi:10.1177/0194599815599381.
Stephen MC, et al. A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children. Otolaryngol Head Neck Surg. 2015;153(6):1042-50. PubMed PMID: 26286872.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children. AU - Stephen,Marie Christy Sharafine, AU - Mathew,John, AU - Varghese,Ajoy Mathew, AU - Kurien,Mary, AU - Mathew,George Ani, Y1 - 2015/08/18/ PY - 2014/10/23/received PY - 2015/07/16/accepted PY - 2015/8/20/entrez PY - 2015/8/20/pubmed PY - 2016/4/5/medline KW - auditory brainstem response audiometry KW - chloral hydrate KW - midazolam KW - sedation SP - 1042 EP - 50 JF - Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery JO - Otolaryngol Head Neck Surg VL - 153 IS - 6 N2 - 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. SN - 1097-6817 UR - https://www.unboundmedicine.com/medline/citation/26286872/A_Randomized_Controlled_Trial_Comparing_Intranasal_Midazolam_and_Chloral_Hydrate_for_Procedural_Sedation_in_Children_ L2 - http://journals.sagepub.com/doi/full/10.1177/0194599815599381?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -