Acetaminophen (APAP) +/- Oxycodone

Montefiore Medical Center393 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

393

Conditions

Musculoskeletal Pain

Interventions

AcetaminophenDRUG

Acetaminophen 650mg

OxycodoneDRUG

Oxycodone 10mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 hours following treatment

Secondary Outcomes

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.

Time frame: Up to 48 hours following medication administration

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.

Time frame: 2 hours following treatment

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"

Data from ClinicalTrials.gov

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