Brief Summary
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.
Brief Title
Randomized Trial of Two Analgesics in Elderly ED Patients
Detailed Description
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:
1. Oxycodone/acetaminophen (5/325)
2. Ibuprofen/acetaminophen (400/500)
1. Oxycodone/acetaminophen (5/325)
2. Ibuprofen/acetaminophen (400/500)
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Pain
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Complaint of acute pain of \< 7 days duration
* ED attending plans to discharge patient home with an oral analgesic
* Complaint of acute pain of \< 7 days duration
* ED attending plans to discharge patient home with an oral analgesic
Gender
All
Gender Based
false
Keywords
Pain
Elderly
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT02703610
Org Class
Other
Org Full Name
Albany Medical College
Org Study Id
4733
Overall Status
Withdrawn
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Randomized Trial of Two Analgesics in Elderly ED Patients
Primary Outcomes
Outcome Description
Between group difference in change in NRS pain scores at 24 hours
Outcome Measure
Between group difference in change in NRS pain scores
Outcome Time Frame
24 hours
Secondary Outcomes
Outcome Description
Between group difference in change in NRS pain scores at first followup contact
Outcome Time Frame
24-72 hours
Outcome Measure
Between group difference in change in NRS pain scores at first followup contact
Outcome Description
Between group difference in change in NRS pain scores at 48 hours and 72 hours
Outcome Time Frame
48 hours and 72 hours
Outcome Measure
Between group difference in change in NRS pain scores
Outcome Description
Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)
Outcome Time Frame
24 hours, 48 hours and 72 hours
Outcome Measure
Between group difference in side effects
Outcome Description
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Outcome Time Frame
24 hours
Outcome Measure
Change in NRS pre and 2 hours post most recent dose of pain medication taken
Outcome Description
Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)
Outcome Time Frame
24, 48, and 72 hours
Outcome Measure
Between group difference in Likert pain scores
Outcome Description
Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Outcome Time Frame
24, 48, and 72 hours
Outcome Measure
Satisfaction
Outcome Description
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Outcome Time Frame
24-72 hours
Outcome Measure
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.
Outcome Description
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Outcome Time Frame
24-72 hours
Outcome Measure
Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to
Outcome Description
Between group difference in proportion of patients who would want the same medication again
Outcome Time Frame
24-72 hours
Outcome Measure
Want same medication again
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Douglas Barnaby
Investigator Email
dbarnaby@montefiore.org
Investigator Phone
718-920-6626