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Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children

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ClinicalTrials.gov Identifier: NCT04820205
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : May 9, 2022
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 29, 2021
Last Update Posted Date May 9, 2022
Actual Study Start Date  ICMJE September 3, 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 sedation (PSSS= 1,2,3) within 15 minutes % [ Time Frame: 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. %
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • Onset time of sedation (PSSS= 0,1,2,3) (min) [ Time Frame: 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) [ 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
  • Heart rate 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) ]
    Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
  • The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min % [ Time Frame: 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 [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    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 Procedural Sedation in Children
Official Title  ICMJE Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: 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 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 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
    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)
  • Drug: Oral chloral hydrate
    Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
Study Arms  ICMJE
  • Experimental: intranasal dexmedetomdine and kemtaine
    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)
    Intervention: Drug: Intranasal dexmedetomidine and ketamine
  • Active Comparator: oral chloral hydrate
    Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2021)
136
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

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 NCT04820205
Other Study ID Numbers  ICMJE IN DEXKET first
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 May 2022

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