APAP +/- Oxycodone

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04122443
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain	Drug: Acetaminophen; Drug: Oxycodone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Jul 31, 2022
• Actual Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acetaminophen Acetaminophen alone	Drug: Acetaminophen; Acetaminophen 650mg
Active Comparator: Oxycodone/ acetaminophen Oxycodone + acetaminophen	Drug: Acetaminophen; Acetaminophen 650mg; Drug: Oxycodone; Oxycodone 10mg

Outcome Measures

Primary Outcome Measures

1. Pain assessment with numeric rating scale (NRS). [2 hours]

   The Numeric Rating Scale (NRS) for evaluating pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain.

2. Pain assessment with four-item ordinal scale [2 hours]

   The rating is verbal and the subject is asked to describe their pain using descriptors (1)severe, (2)moderate, (3)mild or (4)none

Secondary Outcome Measures

1. Adequacy of analgesia [2 hours]

   This is a single question: Did the medication we gave you control your pain? Answer choices: Yes (it did); No (It did not); and Not sure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months

• Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria:

• Use of an non-steroidal anti-inflammatory drug within the previous six hours

• Use of acetaminophen within the previous six hours

• Use of an opioid within the previous ten days

• Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain

• Gout

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT04122443
• Other Study ID Numbers: 2019-10592
• First Posted: Oct 10, 2019
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• 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
• Additional relevant MeSH terms: Musculoskeletal Pain; Acetaminophen; Oxycodone

Study Results

No Results Posted as of Aug 4, 2022