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Ziconotide: A rapid detoxification protocol for the conversion from intrathecal morphine--the Raffaeli Detoxification Model.

OBJECTIVES
To assess the efficacy and the safety of our rapid detoxificationprotocol in preventing signs and symptoms of withdrawal and pain severity.


DESIGN
Prospective, open-label case series study.


SETTINGS
Public primary care at the Pain and Palliative Care Unit of the Infermi Hospital of Rimini, Italy.


PATIENTS
The authors studied 10 consecutive patients suffering from chronic noncancer pain who were refractory to intrathecal (IT) morphine, and hence indicated for ziconotide therapy.


INTERVENTIONS
IT pump was refilled with saline solution, and each patient received endovenous morphine, oral clonidine, ketoprofen, and lorazepam for the first 3 days, and slow-release tramadol, oral clonidine, and ketoprofen for 10 days. Ziconotide therapy was started at the end of the 2-week detoxification treatment.


MAIN OUTCOME MEASURES
The observer-rated opioid withdrawal scale (OOWS) was used for the assessment of withdrawal signs, visual analogue scale was used for pain intensity assessment, and also adverse events were recorded.


RESULTS
Withdrawal symptoms were experienced by 3 patients (30 percent). Their average OOWS decreased significantly (p < 0.05) from 4.3 +/- 2.5 to 1.7 +/- 0.6 at days 3 and 14 of protocol, respectively, with no increment of pain intensity. Withdrawal symptoms were resolved in 4 days on average without the need of adjuvant medications. One patient with high morphine dosage (20 mg/d), interestingly, did not show any withdrawal symptoms.


CONCLUSIONS
The detoxification protocol was effective in preventing withdrawal signs without increasing pain severity, allowing to rapidly convert IT morphine to ziconotide monotherapy in patients who are refractory to morphine.