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Efficacy and safety of intravenous Meloxicam in subjects with moderate-to-severe pain following bunionectomy: A randomized, double-blind, placebo-controlled trial Efficacy and safety of intravenous Meloxicam in subjects with moderate-to-severe pain following bunionectomy: A randomized, double-blind, placebo-controlled trial
Efficacy and safety of intravenous Meloxicam in subjects with moderate-to-severe pain following bunionectomy: A randomized, double-blind, placebo-controlled trial Efficacy and safety of intravenous Meloxicam in subjects with moderate-to-severe pain following bunionectomy: A randomized, double-blind, placebo-controlled trial

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.

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Key take away

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.

Background

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.

Method

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. 

Result

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.

Conclusion

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.

Source:

Clin J Pain. 2018 Mar 16.

Article:

Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Authors:

Pollak RA et al.

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