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

Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial

Sponsors

Lead Sponsor: Seoul National University Hospital

Source 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 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).

Overall Status Not yet recruiting
Start Date May 1, 2021
Completion Date December 31, 2025
Primary Completion Date December 31, 2025
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes % During pediatric procedural sedation (up to 1 hour)
Secondary Outcome
Measure Time Frame
Onset time of rescue sedation (PSSS =1,2,3) (min) During pediatric procedural sedation (up to 3 hour)
Duration of rescue sedation = Recovery time (PSSS =4,5) During pediatric procedural sedation (up to 3 hour)
PSSS(Pediatric Sedation State Scale, 0-5) During pediatric procedural sedation (up to 3 hour)
HR during sedation (/min) During pediatric procedural sedation (up to 3 hour)
SpO2 during sedation (%) During pediatric procedural sedation (up to 3 hour)
Respiratory rate during sedation (/min) During pediatric procedural sedation (up to 3 hour)
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % During pediatric procedural sedation (up to 3 hour)
The incidence of respiratory intervention: Manual ventilation or Artificial airway % During pediatric procedural sedation (up to 3 hour)
The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) % During pediatric procedural sedation (up to 3 hour)
The incidence of significant apnea (>20seconds) % During pediatric procedural sedation (up to 3 hour)
The lowest SpO2 value (%) During pediatric procedural sedation (up to 3 hour)
The incidence of hemodynamic intervention: fluid management, intravenous medication % During pediatric procedural sedation (up to 3 hour)
The incidence of significant bradycardia (-30% from baseline) % During pediatric procedural sedation (up to 3 hour)
The incidence of significant hypotension (-30% from baseline) % During pediatric procedural sedation (up to 3 hour)
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) During pediatric procedural sedation (up to 3 hour)
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) During pediatric procedural sedation (up to 3 hour)
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) During pediatric procedural sedation (up to 3 hour)
The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) During pediatric procedural sedation (up to 3 hour)
The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min % During pediatric procedural sedation (up to 3 hour)
The incidence of Completion of procedure During pediatric procedural sedation (up to 3 hour)
Total cost of sedation (KRW) During pediatric procedural sedation (up to 1 day)
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intranasal dexmedetomidine and ketamine

Description: 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)

Arm Group Label: intranasal dexmedetomdine and kemtaine

Intervention Type: Drug

Intervention Name: Oral chloral hydrate

Description: 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)

Arm Group Label: oral chloral hydrate

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 7 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Jin-Tae Kim, MD. PhD

Phone: 82-2-2072-3664

Email: [email protected]

Location
Facility: Jin-Tae Kim
Location Countries

Korea, Republic of

Verification Date

March 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Jin-Tae Kim

Investigator Title: Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: intranasal dexmedetomdine and kemtaine

Type: Experimental

Description: 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)

Label: oral chloral hydrate

Type: Active Comparator

Description: 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)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov

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