Sedation
Conditions
Keywords
pediatric, procedural sedation, chloral hydrate, intranasal dexmedetomidine, intranasal ketamine
Brief 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 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).
Interventions
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 (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes % | During pediatric procedural sedation (up to 1 hour) | Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of sedation = Recovery time (PSSS= 4,5) (min) | During pediatric procedural sedation (up to 3 hour) | Pediatric Sedation State Scale= 4,5 after recovery of sedation |
| PSSS(Pediatric Sedation State Scale, 0-5) | During pediatric procedural sedation (up to 3 hour) | 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 |
| Heart rate during sedation (/min) | During pediatric procedural sedation (up to 3 hour) | HR(/min) at Baseline(T0), q 10min |
| SpO2 during sedation (%) | During pediatric procedural sedation (up to 3 hour) | SpO2(%) by pulse oximetry at Baseline(T0), q 10min |
| Respiratory rate during sedation (/min) | During pediatric procedural sedation (up to 3 hour) | RR(/min) at Baseline(T0), q 10min |
| the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % | During pediatric procedural sedation (up to 3 hour) | the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % |
| The incidence of respiratory intervention: Manual ventilation or Artificial airway % | During pediatric procedural sedation (up to 3 hour) | The incidence of respiratory intervention: Manual ventilation or Artificial airway |
| 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 desaturation (SpO2 \< 95% or -10% from baseline, \>10 seconds) % |
| The incidence of significant apnea (>20seconds) % | During pediatric procedural sedation (up to 3 hour) | The incidence of significant apnea (\>20seconds) % |
| The lowest SpO2 value (%) | During pediatric procedural sedation (up to 3 hour) | The lowest SpO2 value (%) |
| Onset time of sedation (PSSS= 0,1,2,3) (min) | During pediatric procedural sedation (up to 3 hour) | Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration. |
| The incidence of significant bradycardia (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) | The incidence of significant bradycardia (-30% from baseline) % |
| The incidence of significant hypotension (-30% from baseline) % | During pediatric procedural sedation (up to 3 hour) | The incidence of significant hypotension (-30% from baseline) % |
| Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) | During pediatric procedural sedation (up to 3 hour) | Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) |
| Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) | During pediatric procedural sedation (up to 3 hour) | Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) |
| Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) | During pediatric procedural sedation (up to 3 hour) | Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) |
| The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) | During pediatric procedural sedation (up to 3 hour) | Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) |
| The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min % | During pediatric procedural sedation (up to 3 hour) | Failure of adequate sedation (PSSS= 0, 4,5) after 30 min % |
| The incidence of completion of procedure | During pediatric procedural sedation (up to 3 hour) | Completion of procedure |
| Total cost of sedation (KRW), optional | During pediatric procedural sedation (up to 1 day) | Total cost of sedation (KRW), if applicable |
| The incidence of hemodynamic intervention: fluid management, intravenous medication % | During pediatric procedural sedation (up to 3 hour) | The incidence of hemodynamic intervention: fluid management, intravenous medication % |
Countries
South Korea
Outcome results
None listed