None listed
Conditions
Interventions
Drug : Experimental group : Intranasal Dexmedetomidine 2mcg/kg + Ketamine 3mg/kg via atomizer for pediatric procedural sedation
Control group: Oral chloral hydrate 50mg/kg for pediatric procedural sed
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of sedation (PSSS= 0,1,2,3);Duration of sedation = Recovery time (PSSS= 4,5);PSSS, HR, SpO2, RR at Baseline(T0), q 10min (BP measurement when HR 20seconds);The incidence of significant desaturation (SpO2 10 seconds);The incidence of respiratory intervention: Manual ventilation or Artificial airway;The lowest SpO2 value (%);The incidence of significant bradycardia (-30% from baseline);The incidence of significant hypotension (-30% from baseline);The incidence of hemodynamic intervention: fluid management, intravenous medication;Patients’ acceptance (1=excellent, 2=good, 3=fair, 4=poor);Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents);Physicians’ satisfaction (1=excellent, 2=good, 3=fair, 4=poor);Tthe incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc);Failure of adequate sedation (PSSS= 0, 4,5) after 30 min;Rescue sedation agent (method);Type of procedure;Completion of procedure ;Causes of Procedure failure | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Eun Jang
Seoul National University Hospital
Outcome results
None listed