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

Phase 2

Withdrawn

• Conditions: europathic Pain in Complex Lower Limb Trauma; Opioid tolerance in Complex Lower Limb Trauma.; Anaesthesiology - Pain management; Glial activation by opioids acting at TLR4 receptors in Complex Lower Limb Trauma.; Neuropathic Pain in Complex Lower Limb Trauma; Injuries and Accidents - Fractures

• Registration Number: ACTRN12611000118909
• Lead Sponsor: Dr David Lindholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umerical Rating scale of pain (NRS) average of worst two pain scores in a 24 h period.[days 1, 3, 5, 7, 10, 14, day of discharge then one, three and six months.];Leeds Assessment of Neuropathic Symptoms and Signs (LANNS)[days 1, 3, 5, 7, 10, 14, day of discharge then one, three and six months.]

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory. (questionnaire)[At admission (or as soon as competent after admission), at discharge and at one, three and six months.];Profile of Moods States. (questionnaire)[At admission (or as soon as competent after admission), at discharge and at one, three and six months.];Pittsburgh Sleep Quality index. (questionnaire)[At admission (or as soon as competent after admission), at discharge and at one, three and six months.];Opioid Use. Inpatient and outpatient opioid use will be converted to oral morphine equivalents as per the following reference; <br>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[Inpatient use, discharge and at one, three and six months.]