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

Seoul National University

Status: Enrolling

Conditions: Sedation

Treatments: Drug: Intranasal dexmedetomidine and ketamine; Drug: Oral chloral hydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04822064

IN DEXKET rescue

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

intranasal dexmedetomdine and kemtaine

Experimental group

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)

Treatment:

Drug: Intranasal dexmedetomidine and ketamine

oral chloral hydrate

Active Comparator group

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)

Treatment:

Drug: Oral chloral hydrate