Clonidine for Tourniquet-related Pain in Children

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a randomized, placebo-controlled, double-blinded, clinical trial with two parallel groups.

This study investigates the association between a single dose of the drug, Clonidine, and the total amount of opioid administered under and 24 hours after surgery in children undergoing orthopedic limb surgery with the use of tourniquet.

The investigators hypothesize that administration of clonidine to children undergoing limb surgery with the use of inflatable tourniquets would reduce post-procedural pain.

This study is a pilot to obtain an effect size. Based on this the investigators will calculate a sample size for the main trial enabling us to reach a power of 0.8 with a significans level of 0.05.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Odense University Hospital
• Collaborator: Odense Patient Data Explorative Network
• Treatments: Clonidine

Criteria

Inclusion Criteria:

• ASA I + II

• Scheduled for GA and planned for relevant surgical procedure (according to table 1)

• Planned use of surgical tourniquet on upper and/or lower extremity

Exclusion Criteria:

• parental consent missing

• ASA classification >II

• Known diagnosis of QT-prolongation syndrome

• known allergies to clonidine

• known allergies or intolerance to morphine

• daily use of pain killers

• under treatment with antihypertensive and antiarrythmic medications

• status of current or previous prematurity

• planned for peripheral or central nerve block in addition to general anaesthesia