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

Lead Sponsor: Seoul National University Hospital

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).

• Sedation

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

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

Last Name: Jin-Tae Kim, MD. PhD

Phone: 82-2-2072-3664

Email: [email protected]

Korea, Republic of

March 2021

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Jin-Tae Kim

Investigator Title: Professor

• pediatric
• procedural sedation
• chloral hydrate
• intranasal dexmedetomidine
• intranasal ketamine

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)

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)