Clonidine for Tourniquet-related Pain in Children

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.

Conditions

• Polydactyly Toe
• Thumb Hypoplasia
• Trigger Finger
• Polydactyly; Fingers
• Osteomyelitis of Hindfoot
• Osteomyelitis of Midfoot
• Congenital Talipes Equinovarus
• Congenital Talipes Calcaneus
• Tarsal Coalition
• Club Foot
• Clubfoot
• Congenital Knee Deformity
• Leg Length Inequality in Children
• Flatfoot
• Hollow Foot
• Congenital Valgus Foot Deformity
• Polydactylia
• Polysyndactyly
• Syndactyly
• Thumb Aplasia
• Congenital Hand and Foot Deformity
• Subungual Exostosis
• Finger Deformity
• Toe Deformity
• Osteomyelitis of the Foot
• Calcaneus Deformity of Foot
• Congenital Hand Deformity
• Hand Deformities, Congenital
• Valgus Foot Deformity
• Toe Joint Deformity
• Capsulitis of MTP Joint

Interventions

DRUG

Catapresan

The intervention is either a single intravenous bolus of 3mcg/kg Catapresan (150mcg/1ml) or an equal amount of saline at the time of tourniquet inflation.

OTHER

Saline

controlgroup receiving saline

Sponsors & Collaborators

• Odense Patient Data Explorative Network

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Nicola G. Clausen, Ph.D. · Department of Anaesthesiology and Intensive Care at Odense University Hospital

• Tom G. Hansen, Ph.D. · Department of Anaesthesiology and Intensive Care at Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2021-12-20

Completion

2022-01-01

Countries

• Denmark

Study Locations