Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol
Abstract Background Oral chloral hydrate is widely used in pediatric sedation. Intranasal dexmedetomidine has been increasingly used for pediatric sedation; however, its improvement is warranted. The combination of dexmedetomidine with ketamine can improve onset and hemodynamic stability while maint...
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BMC
2023-01-01
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| Online Access: | https://doi.org/10.1186/s13063-022-07033-x |
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| author | Young-Eun Jang Eun-Young Joo Ji-Hyun Lee Eun-Hee Kim Pyoyoon Kang Jung-Bin Park Hee-Soo Kim Jin-Tae Kim |
| author_facet | Young-Eun Jang Eun-Young Joo Ji-Hyun Lee Eun-Hee Kim Pyoyoon Kang Jung-Bin Park Hee-Soo Kim Jin-Tae Kim |
| author_sort | Young-Eun Jang |
| collection | DOAJ |
| container_title | Trials |
| description | Abstract Background Oral chloral hydrate is widely used in pediatric sedation. Intranasal dexmedetomidine has been increasingly used for pediatric sedation; however, its improvement is warranted. The combination of dexmedetomidine with ketamine can improve onset and hemodynamic stability while maintaining sedative efficacy. This study aims to determine the efficacy and safety of intranasal combination of dexmedetomidine and ketamine compared to oral chloral hydrate. Methods This is a prospective, parallel-arm, single-blinded, two-center, superiority randomized controlled trial with 1:1 allocation, designed to compare the effects of intranasal combination of dexmedetomidine and ketamine with those of oral chloral hydrate. We shall enroll 136 patients aged < 7 years old in this study. Prior to the procedure, we shall randomize each patient into the control group (oral chloral hydrate 50 mg/kg) or study group (intranasal dexmedetomidine 2 μg/kg and ketamine 3 mg/kg). The primary outcome will be the rate of achieving an adequate sedation level (6-point Pediatric Sedation State Scale 1, 2, or 3) within 15 min. In addition, we shall measure the sedation time, sedation failure rate, completion of procedure, adverse events, patient acceptance, and physician satisfaction. Discussion This study will provide evidence of the efficacy and safety of the intranasal combination of dexmedetomidine and ketamine in comparison with oral chloral hydrate. Trial registration ClinicalTrials.gov , NCT04820205. Registered on 19th March 2021 |
| format | Article |
| id | doaj-art-2dfcf22dc96f44b6a67c2211ecea34af |
| institution | Directory of Open Access Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| spelling | doaj-art-2dfcf22dc96f44b6a67c2211ecea34af2025-08-19T21:19:44ZengBMCTrials1745-62152023-01-0124111110.1186/s13063-022-07033-xTwo-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocolYoung-Eun Jang0Eun-Young Joo1Ji-Hyun Lee2Eun-Hee Kim3Pyoyoon Kang4Jung-Bin Park5Hee-Soo Kim6Jin-Tae Kim7Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of MedicineAbstract Background Oral chloral hydrate is widely used in pediatric sedation. Intranasal dexmedetomidine has been increasingly used for pediatric sedation; however, its improvement is warranted. The combination of dexmedetomidine with ketamine can improve onset and hemodynamic stability while maintaining sedative efficacy. This study aims to determine the efficacy and safety of intranasal combination of dexmedetomidine and ketamine compared to oral chloral hydrate. Methods This is a prospective, parallel-arm, single-blinded, two-center, superiority randomized controlled trial with 1:1 allocation, designed to compare the effects of intranasal combination of dexmedetomidine and ketamine with those of oral chloral hydrate. We shall enroll 136 patients aged < 7 years old in this study. Prior to the procedure, we shall randomize each patient into the control group (oral chloral hydrate 50 mg/kg) or study group (intranasal dexmedetomidine 2 μg/kg and ketamine 3 mg/kg). The primary outcome will be the rate of achieving an adequate sedation level (6-point Pediatric Sedation State Scale 1, 2, or 3) within 15 min. In addition, we shall measure the sedation time, sedation failure rate, completion of procedure, adverse events, patient acceptance, and physician satisfaction. Discussion This study will provide evidence of the efficacy and safety of the intranasal combination of dexmedetomidine and ketamine in comparison with oral chloral hydrate. Trial registration ClinicalTrials.gov , NCT04820205. Registered on 19th March 2021https://doi.org/10.1186/s13063-022-07033-xDexmedetomidineChloral hydrateIntranasalKetaminePediatric sedation |
| spellingShingle | Young-Eun Jang Eun-Young Joo Ji-Hyun Lee Eun-Hee Kim Pyoyoon Kang Jung-Bin Park Hee-Soo Kim Jin-Tae Kim Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol Dexmedetomidine Chloral hydrate Intranasal Ketamine Pediatric sedation |
| title | Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol |
| title_full | Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol |
| title_fullStr | Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol |
| title_full_unstemmed | Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol |
| title_short | Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol |
| title_sort | two center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children study protocol |
| topic | Dexmedetomidine Chloral hydrate Intranasal Ketamine Pediatric sedation |
| url | https://doi.org/10.1186/s13063-022-07033-x |
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