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. 2010 Jan 20;2010(1):CD006605. doi: 10.1002/14651858.CD006605.pub2

Thimineur 2004.

Methods Case series
Duration: 36 months
Participants N = 38 enrolled
Primary condition: Not reported. Likely back pain since Oswestry Disability Index (ODI) was administered.
Baseline pain score: 8.4 (SD 1.4)/10 VAS
Time since onset: 6.8 (SD 4) years
Mean age: 46.1 (SD 12) years
Female: Not reported
Previous opioid analgesics: All patients had prior opioid exposure, but with dose‐limiting adverse events
Interventions Initial doses not reported for any drug
Intrathecal morphine (n = 9), Titrated to mean 10.8 mg/day
Intrathecal Dilaudid (n = 21), Titrated to mean 13.5 mg/day
Intrathecal fentanyl (n = 24), Titrated to mean 664 ug/day
Intrathecal clonidine (n = 23), Titrated to mean 378 ug/day
Intrathecal baclofen (n = 2), Titrated to mean 120 ug/day
Intrathecal bupivacaine (n = 1), Titrated to 15.0 mg/day
Intrathecal methadone (n = 1), Titrated to 10.0 mg/day
Supplemental analgesics: All patients received other pain therapies, such as oral and transdermal medications, therapeutic injections, and physical therapy
Outcomes Adverse Events
Pain, continuous
Quality of life
Function
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Comparability of patients at baseline and follow‐up (continuous data) 
 All outcomes Low risk Attrition rate relatively low
Selection method random or consecutive Unclear risk Unclear whether either all or consecutive patients were invited
Prospective Low risk Prospective
Free from confounding treatment(s) High risk All patients had additional pain therapies
Patient compliance monitored and reported at at least 85%? Low risk Pump administration
Attrition and right censoring less than 15% (continuous data) 
 All outcomes Low risk Lower than 15%
Funding from a source without financial conflict of interest? High risk Funding by Medtronic