Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
NCT02455726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2015-05-28
Summary
Magnesium exerts analgesic effects in several animal pain models and in patients affected by acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).
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.
Conditions
- Peripheral Arterial Disease
Interventions
- DIETARY_SUPPLEMENT
-
Magnesium oxide
Oral magnesium oxide 300 mg twice a day
- DIETARY_SUPPLEMENT
-
Fructose
Oral fructose 10 g twice a day
- DRUG
-
Oxycodone
Oxycodone hydrochloride 5 mg at 8 am
- DRUG
-
Pregabalin
Pregabalin 25 mg at 8 pm
Sponsors & Collaborators
-
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
lead OTHER
Principal Investigators
-
Monica A Venturini, Doctor
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
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