Comparative Efficacy of 4 Oral Analgesics

Pain Clinical Trial

Official title:

Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455518
• Other study ID #: 2014-4156
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2015
• Last updated: February 7, 2018
• Start date: July 2015
• Est. completion date: October 4, 2017

Study information

• Verified date: February 2018
• Source: Montefiore Medical Center
• 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 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.

Description:

To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:

1. Oxycodone/acetaminophen (5/325)

2. Hydrocodone/acetaminophen (5/325)

3. Codeine/acetaminophen (30/300)

4. Ibuprofen/acetaminophen (400/1000)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: October 4, 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Complaint of acute pain of < 7 days duration

• Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;

• Radiologic evaluation is planned

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

• Opioids taken in the past 24 hours

• Ibuprofen or acetaminophen taken in past 8 hours

• Pregnancy by either urine or serum HCG testing

• Breastfeeding per patient report

• 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

• Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone/acetaminophen

• Hydrocodone/acetaminophen

• Codeine/acetaminophen

• Ibuprofen/acetaminophen

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)	2 hours
Secondary	Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)	1 hour