دورية أكاديمية
Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-controlled Trial.
| العنوان: | Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-controlled Trial. |
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| المؤلفون: | Pollak RA; Endeavor Clinical Trials, San Antonio, TX., Gottlieb IJ; Chesapeake Research Group, Pasadena, MD., Hakakian F; Lotus Clinical Research, Pasadena., Zimmerman JC; Trovare Clinical Research, Bakersfield, CA., McCallum SW; Recro Pharma Inc., Malvern., Mack RJ; Recro Pharma Inc., Malvern., Keller R; Recro Pharma Inc., Malvern., Freyer A; Recro Pharma Inc., Malvern., Du W; Clinical Statistics Consulting, Blue Bell, PA. |
| المصدر: | The Clinical journal of pain [Clin J Pain] 2018 Oct; Vol. 34 (10), pp. 918-926. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 8507389 Publication Model: Print Cited Medium: Internet ISSN: 1536-5409 (Electronic) Linking ISSN: 07498047 NLM ISO Abbreviation: Clin J Pain Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: [New York, N.Y.] : Raven Press, [c1985- |
| مواضيع طبية MeSH: | Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage , Bunion/*surgery , Meloxicam/*administration & dosage , Pain, Postoperative/*drug therapy, Administration, Intravenous ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Double-Blind Method ; Electrocardiography ; Follow-Up Studies ; Humans ; Internal Fixators ; Meloxicam/adverse effects ; Middle Aged ; Osteotomy ; Pain Measurement ; Severity of Illness Index ; Treatment Outcome |
| مستخلص: | Objective: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30 mg) in patients with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation. Materials and Methods: Patients who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30 mg (n=100) or placebo (n=101) administered once daily. The primary efficacy endpoint was the Summed Pain Intensity Difference over 48 hours (SPID48). Secondary efficacy endpoints included sum of time-weighted pain intensity differences (SPID) values at other timepoints/intervals, time to first use of rescue analgesia, and number of rescue doses taken. Safety assessments included the incidence of adverse events (AEs), physical examinations, laboratory tests, 12-lead electrocardiography, and wound healing. Results: Patients randomized to meloxicam IV 30 mg exhibited a statistically significant difference in SPID48 versus the placebo group (P=0.0034). Statistically significant differences favoring meloxicam IV over placebo were also observed for secondary efficacy endpoints, including SPID at other times/intervals (SPID6: P=0.0153; SPID12: P=0.0053; SPID24: P=0.0084; and SPID24-48: P=0.0050) and first use of rescue medication (P=0.0076). Safety findings indicated that meloxicam IV 30 mg was generally well tolerated; no serious AEs or bleeding events were observed. Most AEs were assessed by the investigator to be mild in intensity, and no patients discontinued due to AEs. There were no meaningful differences between the study groups in vital signs, electrocardiographic findings, or laboratory assessments. In most cases, investigators found that wound healing followed a normal course and mean wound-healing satisfaction scores were similar for meloxicam IV 30 mg and placebo. Discussion: Meloxicam IV doses of 30 mg provided effective pain relief when administered once daily by bolus injection to patients with moderate-to-severe pain following bunionectomy, and had an acceptable safety profile. |
| المشرفين على المادة: | 0 (Anti-Inflammatory Agents, Non-Steroidal) VG2QF83CGL (Meloxicam) |
| تواريخ الأحداث: | Date Created: 20180320 Date Completed: 20191010 Latest Revision: 20191010 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1097/AJP.0000000000000609 |
| PMID: | 29554032 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1536-5409 |
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| DOI: | 10.1097/AJP.0000000000000609 |