Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute Renal Colic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.
研究概览
简要总结
Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.
详细描述
This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.
Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.
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
- Double (Participant, Investigator)
盲法说明
Participant and study team (i.e. investigators responsible for collecting pain scores) will be blinded as to treatment arm for the duration of the study (2 hours after initiation or until ED discharge/hospital admission). Treatment team (physicians and nurses involved in ED care of the patient) will be unblinded to maintain participant safety and proper medication administration. While the treating physician may be aware of what drugs have been ordered, the need for rescue medications is based on patient pain score at the 30-minute point.
入排标准
- 年龄范围
- 19 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 - 65
- •ED presentation with pain associated with suspected renal colic
- •Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)
排除标准
- •Age < 19 or ≥ 66
- •Allergy to any study medication
- •Known pregnancy or breastfeeding
- •Received opioid prior to enrollment
- •Received IV Lidocaine during current ED visit
- •Known chronic renal disease
- •Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)
- •Unable to consent
研究组 & 干预措施
Pramipexole and half-standard dose of morphine
0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine
干预措施: Morphine (Drug)
Standard dose of morphine and placebo
0.1mg/kg of IV morphine in combination with a placebo pill
干预措施: Morphine (Drug)
Pramipexole and half-standard dose of morphine
0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine
干预措施: Pramipexole (Drug)
Standard dose of morphine and placebo
0.1mg/kg of IV morphine in combination with a placebo pill
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.
时间窗: 120 minutes
Dose of opioid measured in mg/kg
Proportion of patients who require rescue medications at 30 minutes post-randomization.
时间窗: 30 minutes
Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization.
时间窗: 120 minutes
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
次要结局
- Time to reach effective pain reduction (defined as at least a 50% improvement in pain scores) within 120 minutes of treatment.(120 minutes)
- Subjective effects of the drugs measured by scores on the drug effects questionnaire.(120 minutes)