Randomized Trial of Two Analgesics in Elderly ED Patients

Study Overview
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Brief Summary
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The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.

Detailed Description
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To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows: Oxycodone/acetaminophen (5/325) Ibuprofen/acetaminophen (400/500)

Official Title
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Randomized Trial of Two Analgesics in Elderly ED Patients

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxycodone/acetaminophen
* Drug: Ibuprofen/acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complaint of acute pain of < 7 days duration ED attending plans to discharge patient home with an oral analgesic Exclusion Criteria: Inability to confirm reliable means of phone followup. Past use of methadone Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy History of an adverse reaction to any of the study medications Ibuprofen or acetaminophen or opioids taken in past 4 hours History of peptic ulcer disease Report of any prior use of recreational narcotics 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone/acetaminophen<br>Oxycodone/acetaminophen (5 mg/325 mg) | Drug: Oxycodone/acetaminophen<br>* Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen<br>* Other names: Percocet;|
| Active Comparator: Ibuprofen/acetaminophen<br>Ibuprofen/acetaminophen (400 mg/500 mg) | Drug: Ibuprofen/acetaminophen<br>* Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in change in NRS pain scores | Between group difference in change in NRS pain scores at 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group difference in change in NRS pain scores at first followup contact | Between group difference in change in NRS pain scores at first followup contact | 24-72 hours | 
| Between group difference in change in NRS pain scores | Between group difference in change in NRS pain scores at 48 hours and 72 hours | 48 hours and 72 hours | 
| Between group difference in side effects | Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation) | 24 hours, 48 hours and 72 hours | 
| Change in NRS pre and 2 hours post most recent dose of pain medication taken | Change in NRS pre and 2 hours post most recent dose of pain medication taken | 24 hours | 
| Between group difference in Likert pain scores | Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe) | 24, 48, and 72 hours | 
| Satisfaction | Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied | 24, 48, and 72 hours | 
| Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. | Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. | 24-72 hours | 
| Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to | Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to | 24-72 hours | 
| Want same medication again | Between group difference in proportion of patients who would want the same medication again | 24-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Elderly