Acetaminophen (APAP) +/- Oxycodone

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122443
• Other study ID #: 2019-10592
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Drug:
• Acetaminophen
Acetaminophen 650mg
• Oxycodone
Oxycodone 10mg

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	Change in Pain Assessment	Stage 1 (Open label): No Outcome Measures assessed; Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.	2 hours following treatment
Secondary	Sustained Pain Relief	Stage 1 (Open label): No Outcome Measures assessed; Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.	Up to 48 hours following medication administration
Secondary	Adequacy of Analgesia	Stage 1 (Open label): No Outcome Measures assessed; Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.	2 hours following treatment
Secondary	Satisfaction With Medication	Stage 1 (Open label): No Outcome Measures assessed; Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"	2 hours following treatment
Secondary	Medication-related Adverse Events	Stage 1 (Open label): No Outcome Measures assessed; Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.	2 hours following treatment