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Clinical Trial
Ziconotide: A rapid detoxification protocol for the conversion from intrathecal morphine--the Raffaeli Detoxification Model.
- William Raffaeli, Donatella Righetti, Donatella Sarti, Marco Balestri, Isabella Ferioli, Maria Cristina Monterubbianesi, and Alessandro Caminiti.
- Department of Palliative Care and Pain Therapy, Infermi Hospital, Rimini, Italy.
- J Opioid Manag. 2011 Jan 1;7(1):21-6.
ObjectivesTo assess the efficacy and the safety of our rapid detoxificationprotocol in preventing signs and symptoms of withdrawal and pain severity.DesignProspective, open-label case series study.SettingsPublic primary care at the Pain and Palliative Care Unit of the Infermi Hospital of Rimini, Italy.PatientsThe authors studied 10 consecutive patients suffering from chronic noncancer pain who were refractory to intrathecal (IT) morphine, and hence indicated for ziconotide therapy.InterventionsIT 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 MeasuresThe 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.ResultsWithdrawal 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.ConclusionsThe 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.
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