New μ₁-opioid receptor agonist for emergency pain relief in outpatient clinic: open observational nonrandomized uncontrolled study

Abstract

BACKGROUND: High-intensity pain is a common problem in outpatient practice, and adequate examination and interventional treatment may be complicated. An effective, safe, and fast pain relief method should be established. AIM: To evaluate the efficacy and safety of the use of the analgesic Tafalgin in the outpatient clinic for relief of intense pain due to various causes and compare the efficacy of different Tafalgin dosages. MATERIALS AND METHODS: Twenty-two patients with high-intensity pain (≥7 points on a numeric rating scale, NRS) were studied. All patients were administered Tafalgin once subcutaneously; pain relief, duration of the analgesic effect, and side effects were observed. Additionally, the differences in the effectiveness and safety of two different doses (i.e., 4 and 7 mg) were analyzed. RESULTS: Average pain intensity at rest before the injection was 9±2 points according to NRS, and pain intensity in movement was 9±1. After Tafalgin injection, average pain intensity decreased to 3±3 points on NRS (pain intensity at rest and in movement were the same). The initial analgesic effect onset time was 17±9 minutes and average duration of the effect was 202±75 minutes. Adverse events (AE) occurred in 8 of 22 patients (36%); all AEs were mild, did not require any treatment, and regressed spontaneously. Differences in efficacy of two Tafalgin doses were noted: after the injection, pain intensity decreased to 6±3 and 2±2 points in the 4 (p=0.16) and 7 mg (p 0,001) groups, respectively. No difference was found between the two groups in effect onset time, effect duration, and number of AEs. CONCLUSION: Tafalgin demonstrated a strong analgesic effect in intense pain relief; the 7 mg dose demonstrated a satisfactory result and should be prefer for most patients suffering high-intensity pain. In therapeutic dosages, Tafalgin is a well-tolerated treatment, and good adherence to medication was noted.