Comparison of intranasally given drug dexmedetomidine withN2O (=laughing gas) for sedation for small procedures in children'semergency department.

Phase 1

• Conditions: sedation for emergency procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-003773-17-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children at the age of 3 - 15 years who present to the emergency
department
•extremity fracture/luxation that require reduction or burn less than 4% of body surface area
•Previously healthy (ASA I and II)
•Swedish speaking

Are the trial subjects under 18? yes
Number of subjects for this age range: 156
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

Exclusion Criteria

•ASA classification = III (see Supplement 11)
•Current respiratory tract infection
•Ear infection
•Sinusitis
•Pertussis within 6 months
•Any symptoms of breathing difficulty
•Active and uncontrolled vomiting
•Impaired level of consciousness
•Psychiatric issues
•Hypersensitivity for dexmedetomidine or N2O.
•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.
oadvanced heart block (grade 2 or 3) unless paced
ouncontrolled hypotension
oacute cerebrovascular conditions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified