Does adjunctive therapy with Minocycline improve pain and opioid effectiveness in complex lower limb trauma? - A prospective randomised controlled trial.
Dr David Lindholm
90 participants
Oct 1, 2013
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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
Exclusion Criteria11
- Patients less than 18 years of age and greater than 65 years of age.
- Death is imminent (less than 24 hours).
- Patient not expected to survive 28 days because of an irreversible medical condition such as poorly controlled neoplasm or other end-stage disease.
- Pregnant or breast feeding.
- Patients with pre-burn psychiatric condition associated with psychotic or delusional symptomatology.
- Patients with drug and alcohol dependence.
- Patients with known hypersensitivity to minocycline or other tetracyclines.
- Patients with known hypersensitivity to ketamine.
- Patients with known hypersensitivity to pregabalin.
- History of active persistent pain syndrome at time of admission
- Opioid therapy in the two weeks preceding admission
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12611000118909