postoperative agitation MedDRA version: 18.0 Level: LLT Classification code 10056436 Term: Psychomotor agitation System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Catapresan solution for injection 150 micg/ml
Product Name: Catapresan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: clonidine hydrochloride
Other descriptive name: CLON
Sponsors
Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: ASA >2 Premedication with Clonidin. Ex-premature (born before week 37+0 AND 50 kg Allergy to Clonidin. Patients treated with methylphenidate / Concerta.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain reduction. 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. | — |
Countries
Denmark
Contacts
Public ContactMogens Ydemann
Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology
Outcome results
None listed