Sedation Clinical Trial
Official title:
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial
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).
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 7 Years |
| Eligibility | Inclusion Criteria: - Pediatric patients who need procedural sedation (Age < 7 years) - ASA (American Society of Anesthesiologists) physical status 1-3 - Failed to induce sedation with oral chloral hydrate 50mg/kg Exclusion Criteria: - ASA (American Society of Anesthesiologists) physical status 4-5 - History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate - Recent administration of Alpha 2 adrenergic receptor agonist or antagonist - Cannot administrate oral medication (e.g. Swallowing difficulty) - Cannot administrate intranasal medication(e.g. Excessive rhinorrhea) - Unstable vital signs, Unstable arrhythmia |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Jin-Tae Kim | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
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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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes % | Success rate of adequate rescue sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. % | During pediatric procedural sedation (up to 1 hour) | |
| Secondary | Onset time of rescue sedation (PSSS =1,2,3) (min) | Onset time of rescue sedation (Pediatric Sedation State Scale= 1,2,3) after rescue sedative administration. | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | Duration of rescue sedation = Recovery time (PSSS =4,5) | Pediatric Sedation State Scale= 4,5 after recovery of sedation | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | 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) | |
| Secondary | HR during sedation (/min) | HR(/min) at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | SpO2 during sedation (%) | SpO2(%) by pulse oximetry at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | Respiratory rate during sedation (/min) | RR(/min) at Baseline(T0), q 10min | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | The incidence of significant apnea (>20seconds) % | The incidence of significant apnea (>20seconds) % | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | The lowest SpO2 value (%) | The lowest SpO2 value (%) | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | 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) | |
| Secondary | The incidence of significant bradycardia (-30% from baseline) % | The incidence of significant bradycardia (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | The incidence of significant hypotension (-30% from baseline) % | The incidence of significant hypotension (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min % | The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min % | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | The incidence of Completion of procedure | The incidence of Completion of procedure | During pediatric procedural sedation (up to 3 hour) | |
| Secondary | Total cost of sedation (KRW) | Total cost of sedation (KRW) | During pediatric procedural sedation (up to 1 day) |
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