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Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

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ClinicalTrials.gov Identifier: NCT04822064
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE March 19, 2021
First Posted Date  ICMJE March 30, 2021
Last Update Posted Date March 30, 2021
Estimated Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes % [ Time Frame: During pediatric procedural sedation (up to 1 hour) ]
Success rate of adequate rescue sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • Onset time of rescue sedation (PSSS =1,2,3) (min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    Onset time of rescue sedation (Pediatric Sedation State Scale= 1,2,3) after rescue sedative administration.
  • Duration of rescue sedation = Recovery time (PSSS =4,5) [ Time Frame: 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) [ Time Frame: 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
  • HR during sedation (/min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    HR(/min) at Baseline(T0), q 10min
  • SpO2 during sedation (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    SpO2(%) by pulse oximetry at Baseline(T0), q 10min
  • Respiratory rate during sedation (/min) [ Time Frame: 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) % [ 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 respiratory intervention: Manual ventilation or Artificial airway % [ Time Frame: 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) % [ 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 apnea (>20seconds) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The incidence of significant apnea (>20seconds) %
  • The lowest SpO2 value (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The lowest SpO2 value (%)
  • The incidence of hemodynamic intervention: fluid management, intravenous medication % [ Time Frame: 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) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The incidence of significant bradycardia (-30% from baseline) %
  • The incidence of significant hypotension (-30% from baseline) % [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ 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 Rescue sedation failure (PSSS =0,4,5) after 30 min % [ 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 Completion of procedure [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The incidence of Completion of procedure
  • Total cost of sedation (KRW) [ Time Frame: During pediatric procedural sedation (up to 1 day) ]
    Total cost of sedation (KRW)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
Official Title  ICMJE Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial
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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: Intranasal dexmedetomidine and ketamine
    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)
  • Drug: Oral chloral hydrate
    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)
Study Arms  ICMJE
  • Experimental: intranasal dexmedetomdine and kemtaine
    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)
    Intervention: Drug: Intranasal dexmedetomidine and ketamine
  • Active Comparator: oral chloral hydrate
    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)
    Intervention: Drug: Oral chloral hydrate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2021)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pediatric patients who need procedural sedation (Age < 7 years)
  • ASA (American Society of Anesthesiologists) physical status 1-3
  • Failed to induce sedation with oral chloral hydrate 50mg/kg

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jin-Tae Kim, MD. PhD 82-2-2072-3664 jintae73@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04822064
Other Study ID Numbers  ICMJE IN DEXKET rescue
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP