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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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)
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)
Jin-Tae Kim
Seoul, South Korea
RECRUITINGSuccess 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. %
Time frame: During pediatric procedural sedation (up to 1 hour)
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.
Time frame: 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
Time frame: 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
Time frame: During pediatric procedural sedation (up to 3 hour)
HR during sedation (/min)
HR(/min) at Baseline(T0), q 10min
Time frame: During pediatric procedural sedation (up to 3 hour)
SpO2 during sedation (%)
SpO2(%) by pulse oximetry at Baseline(T0), q 10min
Time frame: During pediatric procedural sedation (up to 3 hour)
Respiratory rate during sedation (/min)
RR(/min) at Baseline(T0), q 10min
Time frame: 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) %
Time frame: 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 %
Time frame: 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) %
Time frame: During pediatric procedural sedation (up to 3 hour)
The incidence of significant apnea (>20seconds) %
The incidence of significant apnea (\>20seconds) %
Time frame: During pediatric procedural sedation (up to 3 hour)
The lowest SpO2 value (%)
The lowest SpO2 value (%)
Time frame: 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 %
Time frame: During pediatric procedural sedation (up to 3 hour)
The incidence of significant bradycardia (-30% from baseline) %
The incidence of significant bradycardia (-30% from baseline) %
Time frame: During pediatric procedural sedation (up to 3 hour)
The incidence of significant hypotension (-30% from baseline) %
The incidence of significant hypotension (-30% from baseline) %
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 %
Time frame: During pediatric procedural sedation (up to 3 hour)
The incidence of Completion of procedure
The incidence of Completion of procedure
Time frame: During pediatric procedural sedation (up to 3 hour)
Total cost of sedation (KRW)
Total cost of sedation (KRW)
Time frame: During pediatric procedural sedation (up to 1 day)
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