NCT02455726Unknown不适用
Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia0 个研究点目标入组 150 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- The oxycodone dosage needed to achieve satisfactory analgesia
研究概览
简要总结
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.
详细描述
- Adult patients admitted to our Acute Pain Service for intractable pain will be eligible if they are affected by PAOD at stages III and IV of Lèriche-Fontaine classification, and are opioid-naïve.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (18 years or above)
- •PAOD at stages III and IV according to the Lèriche-Fontaine classification
- •no treatment with opioids at the time of recruitment
排除标准
- •renal failure (serum creatinine ≥ 2.0 mg/dl);
- •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.
研究组 & 干预措施
Mg-group
Experimental
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).
干预措施: Magnesium oxide (Dietary Supplement)
Mg-group
Experimental
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).
干预措施: Oxycodone (Drug)
Mg-group
Experimental
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).
干预措施: Pregabalin (Drug)
C-group
Placebo Comparator
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).
干预措施: Fructose (Dietary Supplement)
C-group
Placebo Comparator
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).
干预措施: Oxycodone (Drug)
C-group
Placebo Comparator
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).
干预措施: Pregabalin (Drug)
结局指标
主要结局
The oxycodone dosage needed to achieve satisfactory analgesia
时间窗: 14 days
Patient's satisfactory analgesia is defined as NRS ≤4
次要结局
- Time to 50% reduction of pain(from 2 to 14 days)
- Level of pain relief(2 days)
- Time to satisfactory analgesia(from 2 to 14 days)
研究者
Monica Aida Venturini
MD
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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