Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

Study Overview
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Brief Summary
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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 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).

Official Title
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Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial

Conditions
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Sedation

Intervention / Treatment
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* Drug: Intranasal dexmedetomidine and ketamine
* Drug: Oral chloral hydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intranasal dexmedetomdine and kemtaine<br>Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg) | Drug: Intranasal dexmedetomidine and ketamine<br>* Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)<br>|
| Active Comparator: oral chloral hydrate<br>Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg) | Drug: Oral chloral hydrate<br>* Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| HR 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) | The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | During pediatric procedural sedation (up to 3 hour) | 
| 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) | 
| The incidence of Completion of procedure | The incidence of Completion of procedure | During pediatric procedural sedation (up to 3 hour) | 
| Total cost of sedation (KRW) | Total cost of sedation (KRW) | During pediatric procedural sedation (up to 1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, procedural sedation, chloral hydrate, intranasal dexmedetomidine, intranasal ketamine