Randomized Trial of Two Analgesics in Elderly ED Patients

Pain Clinical Trial

Official title:

Randomized Trial of Two Analgesics in Elderly ED Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02703610
• Other study ID #: 4733
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: September 2023
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone/acetaminophen
Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen
• Ibuprofen/acetaminophen
Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between group difference in change in NRS pain scores	Between group difference in change in NRS pain scores at 24 hours	24 hours
Secondary	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
Secondary	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
Secondary	Between group difference in side effects	Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)	24 hours, 48 hours and 72 hours
Secondary	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
Secondary	Between group difference in Likert pain scores	Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)	24, 48, and 72 hours
Secondary	Satisfaction	Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied	24, 48, and 72 hours
Secondary	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
Secondary	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
Secondary	Want same medication again	Between group difference in proportion of patients who would want the same medication again	24-72 hours