PMID- 29554032
OWN - NLM
STAT- MEDLINE
DCOM- 20191010
LR  - 20191010
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 34
IP  - 10
DP  - 2018 Oct
TI  - Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe 
      Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-controlled 
      Trial.
PG  - 918-926
LID - 10.1097/AJP.0000000000000609 [doi]
AB  - 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.
FAU - Pollak, Richard A
AU  - Pollak RA
AD  - Endeavor Clinical Trials, San Antonio, TX.
FAU - Gottlieb, Ira J
AU  - Gottlieb IJ
AD  - Chesapeake Research Group, Pasadena, MD.
FAU - Hakakian, Fardin
AU  - Hakakian F
AD  - Lotus Clinical Research, Pasadena.
FAU - Zimmerman, John C
AU  - Zimmerman JC
AD  - Trovare Clinical Research, Bakersfield, CA.
FAU - McCallum, Stewart W
AU  - McCallum SW
AD  - Recro Pharma Inc., Malvern.
FAU - Mack, Randall J
AU  - Mack RJ
AD  - Recro Pharma Inc., Malvern.
FAU - Keller, Rosemary
AU  - Keller R
AD  - Recro Pharma Inc., Malvern.
FAU - Freyer, Alex
AU  - Freyer A
AD  - Recro Pharma Inc., Malvern.
FAU - Du, Wei
AU  - Du W
AD  - Clinical Statistics Consulting, Blue Bell, PA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Administration, Intravenous
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects
MH  - Bunion/*surgery
MH  - Double-Blind Method
MH  - Electrocardiography
MH  - Follow-Up Studies
MH  - Humans
MH  - Internal Fixators
MH  - Meloxicam/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Osteotomy
MH  - Pain Measurement
MH  - Pain, Postoperative/*drug therapy
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2018/03/20 06:00
MHDA- 2019/10/11 06:00
CRDT- 2018/03/20 06:00
PHST- 2018/03/20 06:00 [pubmed]
PHST- 2019/10/11 06:00 [medline]
PHST- 2018/03/20 06:00 [entrez]
AID - 10.1097/AJP.0000000000000609 [doi]
PST - ppublish
SO  - Clin J Pain. 2018 Oct;34(10):918-926. doi: 10.1097/AJP.0000000000000609.