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: 20.0 Level: PT Classification code 10053680 Term: Tourniquet application System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Clonidin-ratiopharm
Product Name: Clonidine hydrochloride
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLONIDINE
CAS Number: 4205-90-7
Other descriptive name: Imidazole
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study i to investigate the association between a single dose clonidine administration (3mcg/kg bodyweight) prior to limb tourniquet inflation and total amount of opiod (mcg/kgBW) administered peri-operatively from induction of anaesthesia. The study is a pilot to obtain an effect size. Based on this we will calculate a sample size for the main trial enabling us to reach a peer of 0.8 with a significans level of 0.05. ;Secondary Objective: total amount of opioid (mg/kgBW) administered during recovery from anaesthesia (from T0 to Trec-END, i.e. from end-of-incision-time to time to transferal to the paediatric ward total amount of opioid (mg/kgBW) administered in the paediatric ward (from Trec-END to T24, i.e. from time to transferal from Recovery until 24 hours after end-of-incision-time Total time-at-recovery (in minutes) Maximal pain at Recovery Occurrence of emergence delir;Primary end point(s): total amount of i.v. morphine in milligram (mg) administered per kg bodyweight;Timepoint(s) of evaluation of this end point: end-of-incision-time (To) through the first 24 hours postoperatively (T24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): total amount of opioid (mg/kgBW) administered during recovery from anaesthesia (from T0 to Trec-END, i.e. from end-of-incision-time to time to transferal to the paediatric ward total amount of opioid (mg/kgBW) administered in the paediatric ward (from Trec-END to T24, i.e. from time to transferal from Recovery until 24 hours after end-of-incision-time Total time-at-recovery (in minutes) Maximal pain at Recovery Occurrence of emergence delir;Timepoint(s) of evaluation of this end point: At the end of general anaesthesia at the end of recovery 24 hours after end-of-incision time | — |
Countries
Denmark
Contacts
Public ContactSection Paediatric Anaesthesia
Department of Anaesthesia and Intensive Care
Outcome results
None listed