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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

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).

Condition or disease Intervention/treatment Phase
Sedation Drug: Intranasal dexmedetomidine and ketamine Drug: Oral chloral hydrate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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)

Active Comparator: oral chloral hydrate
Oral chloral hydrate (50mg/kg) administration to induce 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)




Primary Outcome Measures :
  1. 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. %


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


  4. Heart rate during sedation (/min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    HR(/min) at Baseline(T0), q 10min

  5. SpO2 during sedation (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    SpO2(%) by pulse oximetry at Baseline(T0), q 10min

  6. Respiratory rate during sedation (/min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    RR(/min) at Baseline(T0), q 10min

  7. 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) %

  8. 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

  9. 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) %

  10. The incidence of significant apnea (>20seconds) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The incidence of significant apnea (>20seconds) %

  11. The lowest SpO2 value (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    The lowest SpO2 value (%)

  12. 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 %

  13. 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) %

  14. 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) %

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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 %

  20. The incidence of completion of procedure [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
    Completion of procedure

  21. Total cost of sedation (KRW) [ Time Frame: During pediatric procedural sedation (up to 1 day) ]
    Total cost of sedation (KRW)



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820205


Contacts
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Contact: Jin-Tae Kim, MD, PhD 82-2-2072-3664 jintae73@gmail.com

Locations
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Korea, Republic of
Jin-Tae Kim Recruiting
Seoul, Korea, Republic of
Contact: Jin-Tae Kim, MD. PhD    82-2-2072-3664    jintae73@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Publications:

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04820205    
Other Study ID Numbers: IN DEXKET first
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
pediatric
procedural sedation
chloral hydrate
intranasal dexmedetomidine
intranasal ketamine
Additional relevant MeSH terms:
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Dexmedetomidine
Ketamine
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents