Randomized Trial of Two Analgesics in Elderly ED Patients

• Sponsor: Albany Medical College (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT02703610
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Oxycodone/acetaminophen; Drug: Ibuprofen/acetaminophen	Phase 4

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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of Two Analgesics in Elderly ED Patients
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 30, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxycodone/acetaminophen Oxycodone/acetaminophen (5 mg/325 mg)	Drug: Oxycodone/acetaminophen; Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen; Other Names: Percocet
Active Comparator: Ibuprofen/acetaminophen Ibuprofen/acetaminophen (400 mg/500 mg)	Drug: Ibuprofen/acetaminophen; Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen

Outcome Measures

Primary Outcome Measures

1. Between group difference in change in NRS pain scores [24 hours]

   Between group difference in change in NRS pain scores at 24 hours

Secondary Outcome Measures

1. 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 at first followup contact

2. Between group difference in change in NRS pain scores [48 hours and 72 hours]

   Between group difference in change in NRS pain scores at 48 hours and 72 hours

3. Between group difference in side effects [24 hours, 48 hours and 72 hours]

   Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)

4. Change in NRS pre and 2 hours post most recent dose of pain medication taken [24 hours]

   Change in NRS pre and 2 hours post most recent dose of pain medication taken

5. Between group difference in Likert pain scores [24, 48, and 72 hours]

   Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)

6. Satisfaction [24, 48, and 72 hours]

   Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied

7. Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. [24-72 hours]

   Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.

8. 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]

   Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to

9. Want same medication again [24-72 hours]

   Between group difference in proportion of patients who would want the same medication again

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albany Medical College	Albany	New York	United States	12208

Sponsors and Collaborators

• Albany Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrew Chang, Professor, Albany Medical College
• ClinicalTrials.gov Identifier: NCT02703610
• Other Study ID Numbers: 4733
• First Posted: Mar 9, 2016
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Andrew Chang, Professor, Albany Medical College: Pain; Elderly
• Additional relevant MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Oxycodone

Study Results

No Results Posted as of Jan 13, 2021