Comparison of intranasally given drug dexmedetomidine withintranasal S-keramine for sedation for small procedures in children's emergency department.
- Conditions
- sedation for emergency proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-000057-40-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Children at the age of 1 - 3 years who present to the emergency
department
- A laceration in need of suturing or burn less than 4% of body surface
area
- Weight 10 – 15 kg
- Previously healthy
- Swedish speaking
Are the trial subjects under 18? yes
Number of subjects for this age range: 52
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•ASA classification = III (see Supplement 12)
•Current respiratory tract infection
•Impaired level of consciousness
•Hypersensitivity for dexmedetomidine or S-ketamine.
•Further contraindications named in the product resume for the trial
medicines would categorize the patient as ASA III and therefore not
suitable for this trial.
- advanced heart block (grade 2 or 3) unless paced
- uncontrolled hypotension
- acute cerebrovascular conditions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method