Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children

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 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).

Official Title
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Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: 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 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>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) | Drug: Intranasal dexmedetomidine and ketamine<br>* 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)<br>|
| Active Comparator: oral chloral hydrate<br>Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) | Drug: Oral chloral hydrate<br>* Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 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