To determine the safety and efficiency of novel intravenous (IV) 30 mg Meloxicam among cases with moderate-to-severe pain after a standardised, unilateral bunionectomy with first metatarsal osteotomy and internal fixation.
For the patients who underwent surgery, opioids
have been recommended for many years for peri- and postoperative pain
management. But opioids are related to the number of adverse events such as
mainly respiratory depression, nausea, vomiting, and constipation, in addition
to the risk of opioid dependence and abuse. Therefore, in the present study,
the author demonstrates the safety profile of meloxicam IV that provided
adequate pain relief when injection to subjects with moderate-to-severe pain
following bunionectomy.
To determine the safety and efficiency of novel intravenous
(IV) 30 mg Meloxicam among cases with moderate-to-severe pain after a
standardised, unilateral bunionectomy with first metatarsal osteotomy and
internal fixation.
Participants who satisfied the criteria were categorised
to take either placebo one time a day or bolus injections of 30 mg Meloxicam
intravenously. The estimated pain intensity difference over 48 hours (SPID48)
was considered as the primary endpoint and time to first use of rescue
analgesia, a number of rescue doses taken, and SPID values at other time
points/intervals as secondary outcomes. Laboratory tests, the incidence of
adverse events (AEs), wound healing, physical examinations, and 12-lead
electrocardiography (ECG) were taken as the safety assessments of the analysis.
Participants of Meloxicam group showed a statistically significant
difference in SPID48 and secondary efficacy endpoints, including the first use
of rescue medication and SPID at other times/intervals as compared to the
placebo group. Meloxicam found to be well-tolerated with no bleeding events or
severe AEs. However, no significant difference was noticed between the groups
regarding ECG findings, vital signs, and laboratory estimations. In maximum
cases, researchers observed that wound healing observed a normal course and
mean wound healing satisfaction scores were alike for placebo and Meloxicam IV
30mg.
Individuals with moderate-to-severe pain following
bunionectomy showed reduced pain with the administration of 30mg Meloxicam IV bolus
injection once daily with acceptable safety profile.
Clin J Pain. 2018 Mar 16.
Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
Pollak RA et al.
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