Comparison of oral chloral hydrate and combination of intranasal dexmedetomidine and ketamine for procedural sedation in children: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0006358
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

? Pediatric patients who need procedural sedation, Age < 7 years
? ASA (American Society of Anesthesiologists) physical status 1-3
? Parent's approval of written informed consent

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
?Swallowing difficulty (oral administration is not possible)
?Excessive rhinorrhea (intranasal administration is not possible)
?Unstable vital sign (heart rate, blood pressure) or significant arrhythmia
?Recent (< 2 weeks) history of pneumonia, or upper respiratory infection
?Investigator's decision
?General contraindication of Dexmedetomidine, Ketamine, or Chloral hydrate
Do not administer to patients with hypersensitivity or past history hypersensitivity to this drug / Use with caution in patients with 1) cardiovascular disease, 2) impaired heart function, 3) reduced circulatory blood flow, 4) hepatic impairment, 5) renal impairment, 6) old age, 7) patients on hemodialysis, and 8) dependency or past history dependency to medication.
Do not administer to the following patients with: 1) hypersensitivity or past history hypersensitivity to this drug, 2) cerebrovascular disease, hypertension (SBP > 160mmHg, DBP > 100mmHg), Increased intracranial pressure, or severe heart failure, 3) history of seizure, 4) outpatient, 5) eclampsia or preeclampsia, 6) uncontrolled hyperthyroidism, 7) glaucoma or increased intraocular pressure, 8) severe heart failure, 9) surgery in the pharynx, larynx, or trachea without adequate neuromuscular blockade. / Use with caution in patients with 1) alcoholics, 2) using beta-blockers, 3) recent history of unstable angina or myocardial infarction 4) respiratory distress, 5) ocular injury such as penetrating trauma, 6) upper respiratory infection; can increase the risk of respiratory complication such as laryngospasm, and 7) increased cerebrospinal fluid pressure before the induction of anesthesia.
Do not administer to the following patients with: 1) Hepatic or renal impairment, 2) severe heart disease, 3) gastritis 4) hypersensitivity or past history hypersensitivity to this drug, 5)acute intermittent porphyria, and 6) using coumarin-based anticoagulants / Use with caution in patients with 1) fragile 2) respiratory depression, 3) old age and 4) this drug contains yellow 5 (Sunset Yellow FCF, Sunset Yellow FCF), so be careful in patients with hypersensitivity or past history hypersensitivity to this sunset yellow FCF.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes