Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial

Background We hypothesized that intranasal combination of dexmedetomidine (2 μg/kg) and ketamine (3 mg/kg) (IN DEXKET) improves the success rate of sedation in pediatric patients compared with chloral hydrate (CH; 50 mg/kg). Methods This prospective, two-center, single-blinded, randomized controlled...

Full description

Saved in:
Bibliographic Details
Main Authors: Young-Eun Jang, Eun-Young Joo, Jung-Bin Park, Sang-Hwan Ji, Eun-Hee Kim, Ji-Hyun Lee, Hee-Soo Kim, Jin-Tae Kim
Format: Article
Language:English
Published: Korean Society of Anesthesiologists 2025-06-01
Series:Korean Journal of Anesthesiology
Subjects:
Online Access:http://ekja.org/upload/pdf/kja-24815.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849245975399366656
author Young-Eun Jang
Eun-Young Joo
Jung-Bin Park
Sang-Hwan Ji
Eun-Hee Kim
Ji-Hyun Lee
Hee-Soo Kim
Jin-Tae Kim
author_facet Young-Eun Jang
Eun-Young Joo
Jung-Bin Park
Sang-Hwan Ji
Eun-Hee Kim
Ji-Hyun Lee
Hee-Soo Kim
Jin-Tae Kim
author_sort Young-Eun Jang
collection DOAJ
description Background We hypothesized that intranasal combination of dexmedetomidine (2 μg/kg) and ketamine (3 mg/kg) (IN DEXKET) improves the success rate of sedation in pediatric patients compared with chloral hydrate (CH; 50 mg/kg). Methods This prospective, two-center, single-blinded, randomized controlled trial involved 136 pediatric patients (aged < 7 years) requiring procedural sedation. The participants were randomized to receive CH or IN DEXKET via a mucosal atomizer device. The primary outcome was the success rate of sedation (Pediatric Sedation State Scale, scores 1–3) within 15 min. The secondary outcomes included sedation failure at 30 min and overall complications of first-attempt sedation. Results After excluding eight patients, 128 were included (CH = 66, IN DEXKET = 62). IN DEXKET showed a similar sedation success rate (75.8% [47/62] vs. 66.7% [44/66]; P = 0.330) but a lower complication rate (3.2% [2/62] vs. 16.7% [11/66]; P = 0.017) than CH. In the subgroup analysis for patients aged < 1 year, IN DEXKET showed a reduced complication rate than CH (2.6% [1/38] vs. 22.9% [8/35]; P = 0.012). In the subgroup analysis of children aged 1–7 years, IN DEXKET showed a higher sedation success rate within 15 min (79.2% [19/24] vs. 51.6% [16/31]; P = 0.049) and a lower sedation failure after 30 min (0% vs. 29.0% [9/31]; P = 0.003) than CH. Conclusions The intranasal combination of dexmedetomidine (2 μg/kg) and ketamine (3 mg/kg) is a safe and effective alternative to CH (50 mg/kg) for sedation in pediatric patients aged < 7 years.
format Article
id doaj-art-a6ea98d2337949bbb77ce10e455c4ad7
institution Kabale University
issn 2005-6419
2005-7563
language English
publishDate 2025-06-01
publisher Korean Society of Anesthesiologists
record_format Article
series Korean Journal of Anesthesiology
spelling doaj-art-a6ea98d2337949bbb77ce10e455c4ad72025-08-20T03:58:39ZengKorean Society of AnesthesiologistsKorean Journal of Anesthesiology2005-64192005-75632025-06-0178324826010.4097/kja.248159056Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trialYoung-Eun Jang0Eun-Young Joo1Jung-Bin Park2Sang-Hwan Ji3Eun-Hee Kim4Ji-Hyun Lee5Hee-Soo Kim6Jin-Tae Kim7 Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, KoreaBackground We hypothesized that intranasal combination of dexmedetomidine (2 μg/kg) and ketamine (3 mg/kg) (IN DEXKET) improves the success rate of sedation in pediatric patients compared with chloral hydrate (CH; 50 mg/kg). Methods This prospective, two-center, single-blinded, randomized controlled trial involved 136 pediatric patients (aged < 7 years) requiring procedural sedation. The participants were randomized to receive CH or IN DEXKET via a mucosal atomizer device. The primary outcome was the success rate of sedation (Pediatric Sedation State Scale, scores 1–3) within 15 min. The secondary outcomes included sedation failure at 30 min and overall complications of first-attempt sedation. Results After excluding eight patients, 128 were included (CH = 66, IN DEXKET = 62). IN DEXKET showed a similar sedation success rate (75.8% [47/62] vs. 66.7% [44/66]; P = 0.330) but a lower complication rate (3.2% [2/62] vs. 16.7% [11/66]; P = 0.017) than CH. In the subgroup analysis for patients aged < 1 year, IN DEXKET showed a reduced complication rate than CH (2.6% [1/38] vs. 22.9% [8/35]; P = 0.012). In the subgroup analysis of children aged 1–7 years, IN DEXKET showed a higher sedation success rate within 15 min (79.2% [19/24] vs. 51.6% [16/31]; P = 0.049) and a lower sedation failure after 30 min (0% vs. 29.0% [9/31]; P = 0.003) than CH. Conclusions The intranasal combination of dexmedetomidine (2 μg/kg) and ketamine (3 mg/kg) is a safe and effective alternative to CH (50 mg/kg) for sedation in pediatric patients aged < 7 years.http://ekja.org/upload/pdf/kja-24815.pdfadministration, intranasalchloral hydrateconscious sedationdeep sedationdexmedetomidinedrug-related side effects and adverse reactionshypnotics and sedativesketaminepediatrics
spellingShingle Young-Eun Jang
Eun-Young Joo
Jung-Bin Park
Sang-Hwan Ji
Eun-Hee Kim
Ji-Hyun Lee
Hee-Soo Kim
Jin-Tae Kim
Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
Korean Journal of Anesthesiology
administration, intranasal
chloral hydrate
conscious sedation
deep sedation
dexmedetomidine
drug-related side effects and adverse reactions
hypnotics and sedatives
ketamine
pediatrics
title Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
title_full Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
title_fullStr Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
title_full_unstemmed Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
title_short Comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation: a randomized controlled trial
title_sort comparison of combined intranasal dexmedetomidine and ketamine versus chloral hydrate for pediatric procedural sedation a randomized controlled trial
topic administration, intranasal
chloral hydrate
conscious sedation
deep sedation
dexmedetomidine
drug-related side effects and adverse reactions
hypnotics and sedatives
ketamine
pediatrics
url http://ekja.org/upload/pdf/kja-24815.pdf
work_keys_str_mv AT youngeunjang comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT eunyoungjoo comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT jungbinpark comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT sanghwanji comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT eunheekim comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT jihyunlee comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT heesookim comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial
AT jintaekim comparisonofcombinedintranasaldexmedetomidineandketamineversuschloralhydrateforpediatricproceduralsedationarandomizedcontrolledtrial