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) |
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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 |
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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 |