Does adjunctive therapy with Minocycline improve pain and opioid effectiveness in complex lower limb trauma? - A prospective randomised controlled trial.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000118909

Acronym

MILT trial

Enrollment

Registered

2011-02-02

Start date

2013-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

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

Outcome results