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Objective Diclofenac is an effective and well-tolerated nonsteroidal anti-inflammatory drug ( NSAID) frequently used in the treatment of acute pain. Marketed formulations for parenteral administration usually contain 75 mg/3 mL of diclofenac sodium, which provide limited dosing flexibility, and are usually given intramuscularly. Methods We present a randomized, double-blind, active comparator- and placebo-controlled, parallel-group phase III multicenter study, investigating efficacy and tolerability of a new 1 mL-volume formulation of diclofenac sodium (25, 50 or 75 mg) containing hydroxypropyl-β-cyclodextrin ( HPβCD) as a solubility enhancer. This low-volume formulation allows subcutaneous ( SC), in addition to intramuscular ( IM) administration. Patients developing moderate-to-severe pain (≥ 50 mm on Visual Analogue Scale) after third molar extraction under local anesthesia were randomized to one of the 4 SC injections: 25 mg diclofenac HPβCD ( n = 77), 50 mg diclofenac HPβCD ( n = 76), 75 mg diclofenac HPβCD ( n = 78), or placebo ( n = 75). Results Mean pain intensity difference at 1.5 hours postdose (primary endpoint) was higher in all diclofenac-treated groups than placebo group. The adjusted means (95% CI) were 36.5 (31.7 to 41.2) in diclofenac 25 mg group, 37.3 (32.6 to 42.1) in diclofenac 50 mg group, 37.7 (33.0 to 42.4) in diclofenac 75 mg group, and 12.3 (7.44 to 17.1) in placebo group. Both 25 and 50 mg doses of diclofenac produced significantly greater pain relief than placebo ( P < 0.001 in both comparisons). Conclusion Single SC doses of diclofenac HPβCD of 25 and 50 mg are effective and well tolerated for relieving pain compared with placebo. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this cross‐sectional study was to explore the structural validity and internal consistency reliability of General Anxiety Disorder‐7, Patient Health Questionnaire‐8, 15 and Jaw Functional Limitation Scale‐20 in patients with chronic pain of temporomandibular disorders. Materials and Methods: Validity and reliability were assessed in 129 patients diagnosed according to the diagnostic criteria for temporomandibular disorders. Structural validity was explored using factor analysis, and internal consistency by calculating Cronbach α. Results: Confirmatory factor analysis revealed a suitable 2‐factor model for Patient Health Questionnaire‐8, with Cronbach α of 0.89, and 0.86. One and 2‐factor models were suitable for General Anxiety Disorder‐7, with overall Cronbach α of 0.93 for the 1‐factor model, and 0.91 and 0.84 for both factors in a 2‐factor model. A 4‐factor solution was appropriate for Patient Health Questionnaire‐15, with Cronbach α of 0.72, 0.57, 0.71 and 0.73 for each factor separately. Exploratory factor analysis was conducted to explore the factor structure of Jaw Functional Limitation Scale 20, and a 3‐factor solution was appropriate. Conclusions: This study provides positive evidence of structural validity and internal consistency of these questionnaires in patients with pain of temporomandibular disorders. However, additional testing is required to explore further psychometric properties. [ABSTRACT FROM AUTHOR]