Intranasal dexmedetomidine sedation and analgesia during pediatric emergency room procedures

Phase 1

Conditions: Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-001297-41-FI

Lead Sponsor: Oulu university hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 112

Inclusion Criteria

Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
Are the trial subjects under 18? yes
Number of subjects for this age range: 112
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

Exclusion criteria include:
-Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
-II or III degree AV-blockage without pacemaker
-Uncontrollable hypotension
-Stroke
-Critically ill patients who are admitted to the PICU
-Patients with clear cardiac or respiratory dysfunction
-Lowered level of consciousness
-Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity

A single patient can only participate in this study once.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary end point in this study is the success of the procedure at the first attempt.;Timepoint(s) of evaluation of this end point: The success rate of the first attempt of the procedure is evaluated at the end of the first attempt of the procdure.;Main Objective: Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. ;Secondary Objective: The duration of sedative effects of 1µg/kg intranasal dexmedetomidine spray is assessed.

Secondary Outcome Measures