Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
Summary
In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the success rate of rescue sedation after failed sedation (PSSS=4,5) with chloral hydrate (50mg/kg) The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of rescue sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients after failed sedation attempt with oral chloral hydrate. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).
Timeline
- Start
- 2022-09-22
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Publications
- Background Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
- Background Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.
- Background Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
- Background Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
- Background Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.
- Background Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
- Background Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22.
- Background Poonai N, Canton K, Ali S, Hendrikx S, Shah A, Miller M, Joubert G, Rieder M, Hartling L. Intranasal ketamine for procedural sedation and analgesia in children: A systematic review. PLoS One. 2017 Mar 20;12(3):e0173253. doi: 10.1371/journal.pone.0173253. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chloral Hydrate | Small molecule | 50 mg/kg | Oral |
| Subject | Dexmedetomidine | Other / unclassified | 2 ug/kg | Intranasal |
| Subject | Ketamine | Small molecule | 3 mg/kg | Intranasal |
Indications
No indication recorded.