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Clinical Trials/EUCTR2017-000057-40-SE
EUCTR2017-000057-40-SE
Active, not recruiting
Phase 1

A prospective randomized double-blind studyIntranasal dexmedetomidine versus intranasal S-ketamine for children age1 – 3 years for procedural sedation and analgesia in pediatric emergencydepartment.

Karolinska University Hospital0 sites30 target enrollmentJanuary 13, 2017
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Conditionssedation for emergency proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsDexdorKetanest

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
sedation for emergency procedures
Sponsor
Karolinska University Hospital
Enrollment
30
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 13, 2017
End Date
October 28, 2020
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Children at the age of 1 \- 3 years who present to the emergency
  • •\- A laceration in need of suturing or burn less than 4% of body surface
  • •\- 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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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