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Trial registered on ANZCTR
Registration number
ACTRN12611000118909
Ethics application status
Approved
Date submitted
12/01/2011
Date registered
2/02/2011
Date last updated
15/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Does adjunctive therapy with Minocycline improve pain and opioid effectiveness in complex lower limb trauma? - A prospective randomised controlled trial.
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Scientific title
Does adjunctive therapy with Minocycline improve pain and opioid effectiveness in complex lower limb trauma? - A prospective randomised controlled trial.
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Secondary ID [1]
253394
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Project No 404/10 Alfred Hospital Ethics Committee
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Universal Trial Number (UTN)
U1111-1119-0238
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Trial acronym
MILT trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain in Complex Lower Limb Trauma
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Opioid tolerance in Complex Lower Limb Trauma.
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Glial activation by opioids acting at TLR4 receptors in Complex Lower Limb Trauma.
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Condition category
Condition code
Injuries and Accidents
259086
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0
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Fractures
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Anaesthesiology
259225
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Minocycline 100 mg Twice daily (bd) introduced as soon as possible following trauma to lower limbs continued for 1 month. Minocycline may reduce the need for opioids which are normally used to treat severe pain caused by complex lower limb trauma.
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Intervention code [1]
257840
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Treatment: Drugs
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Comparator / control treatment
Placebo which will be made using the same capsules as the minocycline but filled with a pharmacologically inert substance. The placebo medication will be produced in line with the placebo certificate of compliance. The placebo will be taken taken twice daily (bd) for one month.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Numerical Rating scale of pain (NRS) average of worst two pain scores in a 24 h period.
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Assessment method [1]
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Timepoint [1]
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days 1, 3, 5, 7, 10, 14, day of discharge then one, three and six months.
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Primary outcome [2]
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Leeds Assessment of Neuropathic Symptoms and Signs (LANNS)
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Assessment method [2]
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Timepoint [2]
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days 1, 3, 5, 7, 10, 14, day of discharge then one, three and six months.
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Secondary outcome [1]
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Opioid Use. Inpatient and outpatient opioid use will be converted to oral morphine equivalents as per the following reference;
Anderson R, Saiers J H, Abram S, Schlicht C. Accuracy in Equianalgesic Dosing:Conversion Dilemmas. Journal of Pain and Symptom Management. Vol. 21 No. 5 May 2001. 397-406
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Assessment method [1]
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Timepoint [1]
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Inpatient use, discharge and at one, three and six months.
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Secondary outcome [2]
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Brief Pain Inventory. (questionnaire)
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Assessment method [2]
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Timepoint [2]
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At admission (or as soon as competent after admission), at discharge and at one, three and six months.
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Secondary outcome [3]
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Profile of Moods States. (questionnaire)
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Assessment method [3]
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Timepoint [3]
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At admission (or as soon as competent after admission), at discharge and at one, three and six months.
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Secondary outcome [4]
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Pittsburgh Sleep Quality index. (questionnaire)
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Assessment method [4]
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Timepoint [4]
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At admission (or as soon as competent after admission), at discharge and at one, three and six months.
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Eligibility
Key inclusion criteria
1. Aged between 18 and 65 years. 2. Admitted to The Alfred Hospital Emergency and Trauma Centre (ET&C) with complex lower limb trauma. These fractures would include Distal Femur types A2/3, B2/3, C2/3. Proximal Tibia Types A3, B3, C1/2/3. Tibial Shaft Types B2/3 C1/2/3. Distal Tibia Types A3, B3, C2/3.(20) Simple fractures not specified above with substantial full thickness tissue loss or compartment syndrome requiring fasciotomy or substantial crush mechanism will also be included.3. Low probability of requirement for prolonged ventilation (> 72 hours) 4. Patient is conscious and able to give informed consent OR patient’s person responsible is able to give informed consent on behalf of the patient. 5. Average of worst two pain scores(NRS)preceeding 24 h >6
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients less than 18 years of age and greater than 65 years of age.
2. Death is imminent (less than 24 hours).
3. Patient not expected to survive 28 days because of an irreversible medical condition such as poorly controlled neoplasm or other end-stage disease.
4. Pregnant or breast feeding.
5. Patients with pre-burn psychiatric condition associated with psychotic or delusional symptomatology.
6. Patients with drug and alcohol dependence.
7. Patients with known hypersensitivity to minocycline or other tetracyclines.
8. Patients with known hypersensitivity to ketamine.
9. Patients with known hypersensitivity to pregabalin.
10. History of active persistent pain syndrome at time of admission
11. Opioid therapy in the two weeks preceding admission
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by clinical trials pharmacist not involved in trial.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/10/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian And New Zealand College of Anaesthetists
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Address [1]
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630 St Kilda Rd
Melbourne
Victoria 3004
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr David Lindholm
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Address
The Alfred Hospital Pain Service
C/O Dept. Anaesthesia & Pain Medicine
PO BOX 315
Prahran Victoria 3181
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Patrick Mahar
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Address [1]
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The Alfred Hospital Pain Service
C/O Dept. Anaesthesia & Pain Medicine
PO BOX 315
Prahran Victoria 3181
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Country [1]
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Australia
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Secondary sponsor category [2]
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Individual
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Name [2]
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Dr Alex Konstantatos
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Address [2]
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The Alfred
Commercial Rd Prahran
Victoria 3181
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Country [2]
286712
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260299
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The Alfred Ethics Committee
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Ethics committee address [1]
260299
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PO Box 315
Prahran
Victoria 3181
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Ethics committee country [1]
260299
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Australia
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Date submitted for ethics approval [1]
260299
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16/12/2010
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Approval date [1]
260299
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22/12/2010
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Ethics approval number [1]
260299
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1/10/0404
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Summary
Brief summary
Patients with complex lower limb trauma experience severe pain. Opioids and inflammation activate glia which may increase the severity of pain experienced. Minocycline acts via inhibiting Toll Like Receptor 4 and may reduce pain severity if given early. This and drugs with similar effects at TLR4 receptors appear to work well in animal models of severe pain. Minocycline may also reduce opioid tolerance and opioid side effects particularly respiratory depression.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David Lindholm
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Address
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Dept. of Anaesthesia and Pain Management
The Alfred Hospital
PO BOX 315
Prahran
Victoria
Australia 3181
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Country
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Australia
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Phone
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+61390763176
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr David Lindholm
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Address
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The Alfred Pain Unit
c/o Dept of Anaesthesia & Pain Medicine
PO BOX 315
Prahran Victoria 3181
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Country
15332
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Australia
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Phone
15332
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+61390763176
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Fax
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+61390762813
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Patrick Mahar
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Address
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The Alfred Pain Unit
c/o Dept of Anaesthesia & Pain Medicine
PO BOX 315
Prahran Victoria 3181
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Country
6260
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Australia
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Phone
6260
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+61390763176
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Fax
6260
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+61390762813
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Email
6260
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[email protected]
;
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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