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

Mironer 2001.

Methods Case series
 Duration: 6 months
Participants N=24 enrolled
 Primary condition: Failed back surgery syndrome
Baseline pain score: Mean 8.5 (SD 1.1)/10 VAS
 Time since onset: NR
 Mean age: 51.4 years (Range 39 to 70 years)
 Female: 62.5%
Previous opioid analgesics: All patients had previous intrathecal therapy with morphine, and also morphine with bupivacaine (n = 20), hydromorphone (n = 21), morphine plus clonidine (n = 4), meperidine (n = 4), SNX‐111 (n = 3), or other (n = 5)
Interventions Intrathecal methadone
Initial dose: Mean 9.2 mg/day (range 1.5 to 18 mg/day)
Titrated to mean 16.8 mg/day (range 5 to 36 mg/day) at endpoint
Supplemental analgesia: Not reported
Outcomes Adverse events
 Pain, continuous and proportion with at least 50% relief
 Quality of Life
Notes Data on discontinuation not included in analysis because patients discontinued study opioid but continued treatment on another opioid, therefore not discontinuing from the study or opioids altogether
Risk of bias
Bias Authors' judgement Support for judgement
Comparability of patients at baseline and follow‐up (continuous data) 
 All outcomes Low risk All patients followed up
Selection method random or consecutive Unclear risk Not reported
Prospective Low risk Prospective
Free from confounding treatment(s) Unclear risk None reported
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 All patients followed up
Funding from a source without financial conflict of interest? Unclear risk Not reported, but since generic drugs were administered to patients who already had a pump it seems less likely