Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
NCT ID: NCT02455726
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2015-09-30
2017-12-31
Brief Summary
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We describe the protocol of a single-center randomized double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD.
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Detailed Description
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* Patients enrolled will be randomized to the control group, treated with standard therapy, consisting of an oral administration of oxycodone 5 mg and pregabalin 25 mg per day plus placebo (fructose 10 g) twice a day for two weeks, or to the experimental group, treated with magnesium oxide 300 mg twice a day.
* Randomization will be computer-generated, with allocation concealment obtained using opaque, sequentially numbered and sealed envelopes. Trials participants, care providers, data collectors, outcome assessors and data analysts will be blinded to treatment allocation.
* Patients will be evaluated on the day of hospital admission (day 0) and on days 2, 4, 6, 8, 12, and 14 with the following information being collected: daily oxycodone dose received; patient's perceived average and maximum pain using the Numerical Rating Scale (NRS: 0=no pain to 10=worst possible pain); pain relief using Pain Relief Scale (PRS: 0% no pain relief to 100% complete pain relief); characteristics of the pain, using the Neuropathic Pain Scale (NPS: 10 items); impact of pain on the patient's daily activities, using the Brief Pain Inventory (BPI; 9 items).
* A sample size calculation performed for the primary outcome showed that 150 patients (75 per group) are needed to achieve 90% power to detect a minimum reduction of 30% in oxycodone dosage in the experimental group, after allowing for a drop-out rate of around 20%.
* Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mg-group
Standard therapy plus magnesium oxide.
* Standard therapy: oxycodone 5 mg and pregabalin 25 mg per day for two weeks. Starting by day 2, the opioid dose will be titrated every 48 hours in order to reach the maximum therapeutic goal and to minimize side effects.
* A rescue dose: paracetamol 1g (maximum dose 3 g per day).
Magnesium oxide
Oral magnesium oxide 300 mg twice a day
Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Pregabalin
Pregabalin 25 mg at 8 pm
C-group
Standard therapy plus fructose.
* Standard therapy: oxycodone 5 mg and pregabalin 25 mg per day for two weeks. Starting by day 2, the opioid dose will be titrated every 48 hours in order to reach the maximum therapeutic goal and to minimize side effects.
* A rescue dose: paracetamol 1g (maximum dose 3 g per day).
Fructose
Oral fructose 10 g twice a day
Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Pregabalin
Pregabalin 25 mg at 8 pm
Interventions
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Magnesium oxide
Oral magnesium oxide 300 mg twice a day
Fructose
Oral fructose 10 g twice a day
Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
Pregabalin
Pregabalin 25 mg at 8 pm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PAOD at stages III and IV according to the Lèriche-Fontaine classification
* no treatment with opioids at the time of recruitment
Exclusion Criteria
* congestive heart failure (New York Heart Association, NYHA \> 3);
* treatment with digoxin and/or calcium channel blockers;
* pre-existing neuromuscular diseases;
* chronic diarrhea;
* acute limb ischemia successfully treated with interventional angiography, Fogarty embolectomy and/or surgical revascularization.
18 Years
ALL
No
Sponsors
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Responsible Party
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Monica Aida Venturini
MD
Principal Investigators
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Monica A Venturini, Doctor
Role: PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Other Identifiers
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1601 gluta-aos
Identifier Type: -
Identifier Source: org_study_id
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