Effect of a bolus of clonidine systemically administered on the excitability of the spinal motoneurons of the lower extremity

Phase 1

• Conditions: Peri and post operative pain management; MedDRA version: 17.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002306-21-BE
• Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients aged 6 to 18 years at time of hospital admission
2. Planned hospital admission for tympanosplasty
3. Informed Consent signed by both parents
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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

1. Known hypersensitivity to clonidine or to any component of the Catapressan
2. Patient treated with alpha2 agonists
3. Surgical emergency
4. Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
5. Abnormal heart rhythms
6. Neuromuscular disease
7. Renal impairment
8. Patient treated with methylphenidate
9. Pregnant or breastfeeding woman

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified