Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
研究概览
简要总结
This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).
详细描述
The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary outcome is the between treatment group difference in change in patients' rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients' rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects.
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)
盲法说明
A pharmacist working in an area inaccessible to ED staff will ensure blinding of the study by masking the medication and inserting it into identical unmarked gel capsules, filling any void with small amounts of lactose. Randomization will be performed in blocks of 10 determined by a sequence generated at http://www.randomization.com. The pharmacist will make up numbered research packets based on the random allocation list, each with 5 tablets containing the masked investigational medication. Research packets will be removed sequentially by the nurse from the Pyxis automated medical dispensing system and administered to the study patients in the ED.
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 21 through 64 years of age
- •Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
- •Pain of less than seven days duration
- •Patient speaks Spanish or English
- •The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
- •Patient is going to receive imaging of the painful extremity
- •Clinician judges patient to have capacity to provide informed consent
排除标准
- •Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
- •Any use of methadone currently or previously
- •Chronic condition requiring frequent pain management such as arthritis, sickle cell disease, fibromyalgia, or any neuropathy
- •History of an adverse reaction to any of the study medications
- •Opioids taken in the past 24 hours
- •Ibuprofen or acetaminophen taken in past 24 hours
- •Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
- •Pregnancy by either urine or serum human chorionic gonadotropin testing
- •Breastfeeding per patient report
- •History of peptic ulcer disease
- •Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's, or Cushing's disease
- •Lacerations,
- •Multiple injuries
- •Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine, or St John's Wort
研究组 & 干预措施
hydrocodone/APAP
5 mg hydrocodone + 300 mg acetaminophen
干预措施: hydrocodone/APAP (Drug)
codeine/APAP
30 mg codeine + 300 mg acetaminophen
干预措施: codeine/APAP (Drug)
oxycodone/acetaminophen (APAP)
5 mg oxycodone + 325 mg acetaminophen
干预措施: oxycodone/APAP (Drug)
400 ibuprofen/APAP
400 mg ibuprofen + 1000 mg acetaminophen
干预措施: 400 ibuprofen/APAP (Drug)
800 ibuprofen/APAP
800 mg ibuprofen + 1000 mg acetaminophen
干预措施: 800 ibuprofen/APAP (Drug)
结局指标
主要结局
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
时间窗: Prior to Ingestion of study medication to one hour after ingestion of the study medication
Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.
次要结局
- Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline(Prior to ingestion of study medication to 2 hours after ingestion of the study medication)
- Percentage of Patients Who Received Rescue Medication(Entire two-hour time period)
- Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication(From time of ingestion of study medication to two hours later)
- Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain(End of two-hour time period)
- Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication(From time of ingestion of study medication to one hour later)
研究者
Polly Bijur
Professor of Emergency Medicine
Albert Einstein College of Medicine