Prevent postoperative agitation and pain in childre

Conditions: postoperative agitation
MedDRA version: 18.0Level: LLTClassification code 10056436Term: Psychomotor agitationSystem Organ Class: 100000004852
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-001466-10-DK

Lead Sponsor: Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

children between 1 and 6 years of age
scheduled for Anastasia with Sevofluran
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
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 >2
Premedication with Clonidin.
Ex-premature (born before week 37+0 AND <60 weeks old)
Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
Critical illness with haemodynamic instability.
Active bleeding.
Cancer.
Cardiac condition including arrhythmias.
Malign hyperthermia.
Mental retardation.
Neurological illness with agitation-like symptoms.
Weight >50 kg
Allergy to Clonidin.
Patients treated with methylphenidate / Concerta.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does Clonidine reduce postoperative agitation in children;Secondary Objective: not applicable;Primary end point(s): Postoperative agitation;Timepoint(s) of evaluation of this end point: Measured on the Watcha Scale

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain reduction.<br>Serious side effects during admission and up to 30 days after the operation. ;Timepoint(s) of evaluation of this end point: During recovery, admission and up to 30 days after the operation.