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NCT Number: NCT04820205

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

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).

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Key information

Conditions

Sedation

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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), optional

    Time frame: During pediatric procedural sedation (up to 1 day)

    Total cost of sedation (KRW), if applicable

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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