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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 first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural 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 undergoing procedural sedation. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal dexmedetomdine and kemtaine | Experimental | Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) |
|
| oral chloral hydrate | Active Comparator | Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal dexmedetomidine and ketamine | Drug | Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes % | Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. % | During pediatric procedural sedation (up to 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of sedation (PSSS= 0,1,2,3) (min) | Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration. | During pediatric procedural sedation (up to 3 hour) |
| Duration of sedation = Recovery time (PSSS= 4,5) (min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin-Tae Kim | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26714442 | 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. | |
| 28414899 | Background |
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| Oral chloral hydrate | Drug | Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) |
|
Pediatric Sedation State Scale= 4,5 after recovery of sedation
| During pediatric procedural sedation (up to 3 hour) |
| PSSS(Pediatric Sedation State Scale, 0-5) | 5 Patient is moving in a manner that impedes the proceduralist and requires forceful immobilization. 4 Moving during the procedure that requires gentle immobilization for positioning. 3 Expression of pain or anxiety on face, but not moving or impeding completion of the procedure. 2 Quiet (asleep or awake), not moving during procedure, and no frown (or brow furrow) indicating pain or anxiety. 1 Deeply asleep with normal vital signs, but requiring airway intervention and/or assistance 0 Sedation associated with abnormal physiologic parameters that require acute intervention q 10min | During pediatric procedural sedation (up to 3 hour) |
| Heart rate during sedation (/min) | HR(/min) at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) |
| SpO2 during sedation (%) | SpO2(%) by pulse oximetry at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) |
| Respiratory rate during sedation (/min) | RR(/min) at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) |
| the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % | the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % | During pediatric procedural sedation (up to 3 hour) |
| The incidence of respiratory intervention: Manual ventilation or Artificial airway % | The incidence of respiratory intervention: Manual ventilation or Artificial airway | During pediatric procedural sedation (up to 3 hour) |
| The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) % | The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) % | During pediatric procedural sedation (up to 3 hour) |
| The incidence of significant apnea (>20seconds) % | The incidence of significant apnea (>20seconds) % | During pediatric procedural sedation (up to 3 hour) |
| The lowest SpO2 value (%) | The lowest SpO2 value (%) | During pediatric procedural sedation (up to 3 hour) |
| The incidence of hemodynamic intervention: fluid management, intravenous medication % | The incidence of hemodynamic intervention: fluid management, intravenous medication % | During pediatric procedural sedation (up to 3 hour) |
| The incidence of significant bradycardia (-30% from baseline) % | The incidence of significant bradycardia (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) |
| The incidence of significant hypotension (-30% from baseline) % | The incidence of significant hypotension (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) |
| Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) | Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) | During pediatric procedural sedation (up to 3 hour) |
| Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) | Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) | During pediatric procedural sedation (up to 3 hour) |
| Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) | Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) | During pediatric procedural sedation (up to 3 hour) |
| The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | During pediatric procedural sedation (up to 3 hour) |
| The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min % | Failure of adequate sedation (PSSS= 0, 4,5) after 30 min % | During pediatric procedural sedation (up to 3 hour) |
| The incidence of completion of procedure | Completion of procedure | During pediatric procedural sedation (up to 3 hour) |
| Total cost of sedation (KRW), optional | Total cost of sedation (KRW), if applicable | During pediatric procedural sedation (up to 1 day) |
| 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. |
| 24237879 | 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. |
| 25822924 | 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. |
| 27627818 | 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. |
| 28639236 | 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. |
| 30032884 | 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. |
| 28319161 | 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. |
| 36597163 | Derived | Jang YE, Joo EY, Lee JH, Kim EH, Kang P, Park JB, Kim HS, Kim JT. Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol. Trials. 2023 Jan 3;24(1):2. doi: 10.1186/s13063-022-07033-x. |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D002697 | Chloral Hydrate |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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