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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
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)
Jin-Tae Kim
Seoul, South Korea
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. %
Time frame: During pediatric procedural sedation (up to 1 hour)
Onset time of sedation (PSSS= 0,1,2,3) (min)
Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.
Time frame: 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
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)
Heart rate 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)
Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
Time frame: 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 %
Time frame: During pediatric procedural sedation (up to 3 hour)
The incidence of completion of procedure
Completion of procedure
Time frame: During pediatric procedural sedation (up to 3 hour)
Total cost of sedation (KRW), optional
Total cost of sedation (KRW), if applicable
Time frame: During pediatric procedural sedation (up to 1 day)
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