Oral Aspirin/ketamine versus oral ketamine for emergency department patients with acute musculoskeletal pain.

OBJECTIVE: The purpose of this study is to investigate if an orally administered combination of aspirin and ketamine will provide better analgesia than a ketamine alone in adult patients presenting to the Emergency Department (ED) with acute musculoskeletal pain. METHODS: We conducted a prospective, randomized, open-label trial of ED patients aged 18 and older presenting with moderate to severe acute musculoskeletal pain as defined by an 11-point numeric rating scale (NRS) with an initial score of ≥5. Patients were randomized to receive either 324 mg of VTS-Aspirin™ and 0.5 mg/kg of oral ketamine (AOK) that is directly swallowed or 0.5 mg/kg of oral ketamine (OK) alone that is swished first and then swallowed. Patients were assessed at baseline, 30, 60, 90, and 120 min. The primary outcome was a difference in pain scores between the two groups at 60 min post-administration. Secondary outcomes included adverse events and the need for rescue analgesia. RESULTS: We enrolled 60 patients in the study (30 per group). The difference in mean pain scores at 60 min between the AOK and OK groups was 2.6 [95% CI: 1.38-3.77] showing a lower mean pain score in the OK group. At 60 min, the AOK group had a change in mean pain score from 8.4 to 6.3 (difference 2.1; 95% CI: 1.35-3.00). The OK group had a change in mean pain score from 7.8 to 3.7 (difference 4.1, 95% CI: 3.25-4.90). No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. The most commonly reported adverse effects were dizziness and fatigue. None of the participants required rescue analgesia at 60 min post-medications administration. CONCLUSION: The administration of an oral combination of VTS-Aspirin ™ and ketamine resulted in less analgesia compared to oral ketamine alone, for the short-term treatment of moderate to severe acute musculoskeletal pain in the ED. CLINICALTRIALS: govRegistration: NCT04860804.

Analgesic Efficacy of Oral Aspirin/Ketamine Combination for Management of Acute Musculoskeletal Pain in the Emergency Department - A Proof of Concept Pilot Study.

BACKGROUND: Musculoskeletal pain (MSK) affects one out of three adults and is the most common source of significant long-term pain, physical disability, and under-treatment in the emergency department (ED). OBJECTIVE: We aimed to assess the analgesic efficacy of a combination of oral VTS-Aspirin® (Vitalis Analgesics, New York, NY) and ketamine in managing acute MSK pain in adult ED patients. METHODS: This was a prospective, proof-of-concept, single-arm, pilot study evaluating the analgesic efficacy of a single dose of oral combination of VTS-Aspirin and ketamine in adult ED patients with acute moderate-to-severe MSK pain. The primary outcome included the difference in pain scores on an 11-point numeric pain rating scale at 60 min. Secondary outcomes included the need for rescue analgesia, the occurrence of adverse events at 60 min, and a change in pain scores at 120 min. RESULTS: We enrolled 25 subjects in the study. The mean baseline pain score was 8.6 and the mean pain score at 60 min decreased to 4.8. The oral ketamine dose ranged from 24 mg to 50 mg, with a mean dose of 37.8 mg. No clinically concerning changes in vital signs were noted. No serious adverse events occurred in any of the subjects. Majority of adverse effects were transient and weak in intensity. CONCLUSION: We demonstrated that administration of an oral combination of VTS-Aspirin and ketamine to adult ED patients with acute MSK pain resulted in clinically significant pain relief in 80% of enrolled subjects.

Cardiac conduction disturbances in rheumatologic disease: a cross-sectional study.

BACKGROUND: Cardiovascular abnormalities are common in patients with rheumatologic disorders. Tachy-arrhythmias occur more frequently in these patients than the general population; however, the prevalence of bradyarrhythmias in this group is less clear. This investigation aimed to analyze the incidence and predictors of bradyarrhythmias and conduction disturbances, as well as the presence and influence of cardiologist management, in patients with rheumatologic disorders. METHODS: We performed a retrospective chart review of 57 consecutive patients with rheumatologic conditions evaluated at a tertiary-care safety-net hospital. Conduction disturbances were defined by any electrocardiogram (ECG) finding indicating: bradycardia, sinoatrial block of any degree, atrioventricular nodal block of any degree, left anterior or posterior fascicular block, non-specific intraventricular conduction delay, complete or incomplete right bundle branch block, left bundle branch block, or paced rhythm. Univariate and multivariate analyses were used to assess the association of relative predictors of conduction disturbance, the primary outcome of this investigation, as well as the secondary outcome of cardiologist involvement in patient care. Statistical significance was defined as P<0.05. Variables found to be statistically significant in a univariate analysis were included in a multivariable logistic regression analysis. RESULTS: The most common rheumatologic condition in our patient population was systemic lupus erythematous (21 patients, 36.8%) followed by gout (15 patients, 26.3%), rheumatoid arthritis (13 patients, 22.8%), sarcoidosis (6 patients, 10.5%), and two patients (3.5%) with other autoimmune diseases. A total of 31.6% of patients in this study were found to have conduction disturbances, higher than the prevalence of conduction disturbances in the general population. Multivariate logistic regression analysis showed significantly increased odds for conduction disturbances with increased age (odds ratio (OR): 1.05, 95% confidence interval (CI): 1.01-1.10, P<0.05). Similar analysis for the involvement of a cardiologist in the care of a patient with a rheumatologic disorder found increased odds for cardiologist involvement with advanced age (OR: 1.05, 95% CI: 1.002-1.09, P<0.05) and cardiovascular disease (OR: 5.0, 95% CI 1.24-21.90, P<0.05). CONCLUSION: Prevalence of conduction abnormalities is greater in rheumatologic patients than the general population. Odds for conduction abnormalities increased with age; and the odds of cardiologist involvement increased with age and cardiovascular disease.