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

Ketamine

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).

Intervention / Treatment

  • Intranasal dexmedetomidine and ketamine (DRUG)
    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 (DRUG)
    Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)

Condition or Disease

  • Sedation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Enrollment: 136 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 03, 2021 ACTUAL
    Primary Completion: Dec 31, 2025 ESTIMATED
    Completion Date: Dec 31, 2025 ESTIMATED
    Study First Posted: Mar 29, 2021 ACTUAL
    Last Updated: May 03, 2022

    Sponsors / Collaborators

    Lead Sponsor: Seoul National University Hospital
    Responsible Party: N/A

    Participant Groups

    • 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)

    Eligibility Criteria

    Sex: All
    Maximum Age: 7
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

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    Primary Outcomes

    • Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %

    Secondary Outcomes

    • Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.

    • Pediatric Sedation State Scale= 4,5 after recovery of sedation

    • 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(/min) at Baseline(T0), q 10min

    • SpO2(%) by pulse oximetry at Baseline(T0), q 10min

    • RR(/min) at Baseline(T0), q 10min

    • the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %

    • The incidence of respiratory intervention: Manual ventilation or Artificial airway

    • The incidence of significant desaturation (SpO2 \< 95% or -10% from baseline, \>10 seconds) %

    • The incidence of significant apnea (\>20seconds) %

    • The lowest SpO2 value (%)

    • The incidence of hemodynamic intervention: fluid management, intravenous medication %

    • The incidence of significant bradycardia (-30% from baseline) %

    • The incidence of significant hypotension (-30% from baseline) %

    • Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)

    • Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)

    • Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)

    • Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)

    • Failure of adequate sedation (PSSS= 0, 4,5) after 30 min %

    • Completion of procedure

    • Total cost of sedation (KRW)

    More Details

    NCT Number: NCT04820205
    Other IDs: IN DEXKET first
    Study URL: https://clinicaltrials.gov/study/NCT04820205
    Last updated: Sep 29, 2023