Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
- Conditions
- Sedation
- Interventions
- Registration Number
- NCT04820205
- Lead Sponsor
- Seoul National University Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Pediatric patients who need procedural sedation (Age < 7 years)
- ASA (American Society of Anesthesiologists) physical status 1-3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intranasal dexmedetomdine and kemtaine Intranasal dexmedetomidine and ketamine 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 Oral chloral hydrate Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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 10minHeart 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 (%)
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 %
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) %
Trial Locations
- Locations (1)
Jin-Tae Kim
🇰🇷Seoul, Korea, Republic of