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临床试验/NCT03478423
NCT03478423终止不适用

A Blinded, Randomized Controlled Trial of Opioid Analgesics for the Management of Acute Fracture Pain in Adults Discharged From the Emergency Department

Mount Sinai Hospital, Canada1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年2月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Pain Scores

研究概览

简要总结

Background: Emergency department (ED) providers are frequently challenged with how best to treat acute pain, specifically when non-opioid analgesics are insufficient or contraindicated. Studies have documented older patients presenting to the ED with painful conditions are less likely to receive pain medications than younger patients, and this inadequate pain control has been associated with increased risk of delirium and longer hospital stays. Given the concerns for drug interactions, adverse side effects, over-sedation and addiction; emergency physicians often report uncertainty regarding the ideal choice of opioid analgesic in older adults. There are no guidelines informing best practice for the management of acute pain in this population.

Objective: The primary objective is to compare the efficacy of codeine, oxycodone and hydromorphone for acute fracture pain in patients discharged from the ED.

Methods: This will be a blinded, randomized controlled trial of adults (age ≥ 18) discharged home from the ED with acute pain secondary to an upper extremity, lower extremity, rib, pelvic or vertebral compression fracture. Patients will be randomized to receive a 3-day supply of codeine, oxycodone or hydromorphone. Patients will also be given acetaminophen. Patients will be contacted by phone or email 3 days following their ED visit. The primary outcome will be differences in pain scores at 3 days assessed using the validated Brief Pain Inventory (Short Form). Secondary outcomes will include side effects (ie: confusion, constipation), adverse events (i.e, falls, healthcare visits) and pain interference with daily activity. Patients, physicians and all research staff will be blinded to group allocation.

Importance: All analgesics (including opioids) prescribed to adults are associated with an increased risk of adverse events. This study seeks to inform ED providers of opioid efficacy, side effects and patient-important, functional outcomes in this growing patient population.

详细描述

Introduction :Pain is a major symptom of many patients presenting to the emergency department (ED), with up to 42% of ED visits being related to painful conditions. ED providers are challenged with how best to treat acute pain, specifically when non-opioid analgesics are ineffective or contraindicated. There is considerable debate regarding most appropriate choice of analgesic when treating acute pain. Providers seek to prescribe the most effective analgesic with the least side effects, including the least risk of opioid dependence. Factors contributing to debate around the most appropriate opioid analgesic have also been influenced by pharmaceutical industry marketing and health care systems' efforts to improve clinicians' treatment of pain.

Ontario's most commonly prescribed opioid is codeine. Yet, its utilization as an analgesic is debated in the analgesic literature. Codeine is a prodrug that is metabolized to morphine in the liver. In most people, 5% to 10% of codeine is converted to morphine. Thus, some experts suggest that a 30 mg dose of codeine is considered equivalent to a 3 mg dose of morphine. However, other experts in this area suggest equi-analgesic doses of opioids are equally efficacious in relieving pain. In fact, codeine has been compared to hydrocodone using morphine-equivalent doses and were found equally efficacious at relieving pain the ED in a randomized controlled trial. Two additional randomized controlled trials have compared short acting hydrocodone and short acting oxycodone found them to be equally effective to relieve pain.

Another recent study by Chang et al., reported no statistically significant or clinically important differences in pain reduction at 2 hours after single-dose treatment with ibuprofen and acetaminophen or with 3 different opioid and acetaminophen combination analgesics for patients presenting to the ED with acute extremity pain. The largest difference in decline in mean pain score between any two treatments was 0.9 at the 2-hour time point, a difference that was not statistically significant and was less than 1.3, which was the author's a priori criterion to define a minimal clinically important difference in pain. This study had several limitations including the limited follow-up time of 2 hours, lack of adverse event reporting, and the exclusion of patients over the age of 65 years. This study is one of the only published randomized trials evaluating analgesic efficacy of opioid and non-opioid analgesics for an acutely painful condition.

There is a surprising paucity of studies evaluating analgesic efficacy, particularly after ED discharge, and there are no guidelines informing best practice for the management of acute pain following ED disposition for acute pain. To date, there have not been studies directly comparing the 3 most commonly prescribed opioids in Canadian EDs: codeine, hydromorphone and oxycodone. In light of mounting concern about the misuse of oral opioids, studies are needed to inform policy makers and to assist physicians in making evidence-based decisions about optimal short-term outpatient pain management.

There remains a paucity of data informing ED providers of opioid efficacy and patient important, functional outcomes in adults. Therefore, the objective of this study is to identify a preferred prescribed oral opioid analgesic for outpatient pain management among adults presenting to the ED with an acutely painful condition.

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

Pharmacy will prepare study drugs in opaque vials with identical labels based on a randomization scheme provided by the trial methodologist. The opaque vials will be included in sealed, sequentially numbered study packets that will be replaced as they are used. To avoid potential patient selection and allocation bias, all physicians, nurses, RAs and patients will be blinded to the randomization schedule. Study investigators will be permitted to un-blind the study medication in the event of allergic reaction, consisting of rash and/or airway compromise.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >=18 Years
  • live independently
  • acute pain secondary to an upper extremity, lower extremity, rib, pelvic or vertebral compression fracture occurring within 7 days prior to their visit
  • ED physician intends to prescribe opioid analgesic upon ED discharge

排除标准

  • an allergy to any of the study drug (acetaminophen, polyethylene glycol 3350, codeine, oxycodone, hydromorphone)
  • non-English speaking without an adequate interpreter
  • already on prescribed chronic opioid pain medication
  • ongoing use of sedating medications (e.g., benzodiazepines, antipsychotics)
  • current substance use disorder excluding tobacco
  • on opioid substitution therapy
  • comorbidity representing an absolute or relative contraindication to acute opioid prescribing (ie. any medical condition requiring home oxygen, Addison's disease, dialysis dependence, obstructive sleep apnea on non-invasive positive pressure ventilation, body mass index > 45, Cushing's Disease)
  • moderate to severe dementia
  • inability to follow-up
  • reside in a nursing home or location where a professional dispenses medications

研究组 & 干预措施

Codeine

Experimental

Patients will be provided with 30mg tablets of codeine, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

干预措施: Codeine (Drug)

Oxycodone

Experimental

Patients will be provided with 5mg tablets of oxycodone, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

干预措施: Oxycodone (Drug)

Hydromorphone

Experimental

Patients will be provided with 1mg tablets of hydromorphone, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

干预措施: Hydromorphone (Drug)

结局指标

主要结局

Pain Scores

时间窗: 3 days

Measure the difference in pain scores assessed using the brief pain inventory (short form)

次要结局

  • Adverse Events(3 days)
  • Pain Interference(3 days)
  • Numerical Opioid Side Effects(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Varner, MD

Clinician Scientist

Mount Sinai Hospital, Canada

研究点 (1)

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