Clonidine against compression-pain in children: a pilot study

Phase 1

• Conditions: Pain, which occurs in relation to the use of tourniquets during limb surgery. Tourniquets are positioned on the upper part of the limb in question, inflated and thereby stops perfusion of the limb. This prevents bleeding and provides the surgeon with optimal conditions for fine tissue handling.; MedDRA version: 20.0Level: PTClassification code 10053680Term: Tourniquet applicationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2019-004281-18-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Children age 0-15years
ASA 1+ 2
Scheduled for general anaesthesia and relevant surgical procedure
planned use of surgical tourniquet on upper/lower extremity or both
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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

parental consent missing
ASA >2
known diagnosis of QT-prolongation syndrome
known allergies to clonidine
known allergies or intolerance to morphine
daily use of pain killers

Study & Design

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