Ziconotide: A rapid detoxification protocol for the conversion from intrathecal morphine--the Raffaeli Detoxification Model
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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