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Premedication in paediatric patients: Dose finding study of clonidine administrated as nasal aerosol.

Premedication in paediatric patients: Dose finding study of clonidine administrated as nasal aerosol.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000714-74-SE
Enrollment
Unknown
Registered
2008-02-14
Start date
2008-07-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premedication prior to anaesthesia

Interventions

Trade Name: Clonidinehydroclorid solution Product Name: clonidinehydrochloride solution Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: CLONIDINE HYDROCHLORIDE CAS Number: 4205918 Curr

Sponsors

Institution of Paediatric Anaesthesia and intensiv care, Astrid Lindgren Childrens Hospital, Karolin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ASA class I and II patients 2. Patients between the age of 6 months and 6 years with a weight between 10 and 25 kilogram. 3. Planned for a surgical procedure at Astrid Lindgrens Childrens Hospital which require generell anaesthesia 4. Oral and written consent from the patient/parent Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. Known allergy to clonidine 2. Impaired development/mental handicap which makes grading of sedation impossible 3. Language diffuculties requiring information by interpreter

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the dose of nasal administrated clonidine as an aerosol for preoperative sedation;Secondary Objective: ;Primary end point(s): Comparison of median sedation scores between groups

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026