The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
192
30 mg (1 mL), once daily, by intravenous infusion
1 mL Placebo, once daily, by intravenous infusion
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose)
The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Rating Scale (NRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain".
Time frame: 24 hours after first dose
TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48.
pain relief intensity was recorded using a Likert Scale (Range 0-4) where 0 equates to no pain relief (worse), and 4 equates to the completely pain relief intensity (better). pain relief intensity scores were to be recorded at the following time points: 0.25, 0.5, 1, 1.5, 2 ,3,4,6 ,8,10,12,14,16,18,24,30,36,42 and 48hours post Dose 1. pain relief intensity at each time point were calculated and a time weighted summed pain relief intensity (TOTPAR) was then calculated. Time weighted TOTPAR calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A bigger TOTPAR value was better.
Time frame: 0-48 hours after the first dose
SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 1, 1.5, 2 ,3,4,6 ,8,10,12,14,16,18,24,30,36,42 and 48hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Time frame: 0-48 hours after the first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to the first dose of the remedial analgesia
Time frame: 0-48 hours after the first dose
Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose
Time frame: 0-48 hours after the first dose
Proportion of subjects requiring remedial analgesia
Time frame: 0-48 hours after the first dose
The total amount of remedial analgesia used 24 h and 48 h after the first dose
Time frame: 0-48 hours after the first dose
The subject's analgesic treatment satisfaction score (0-4 point categorical scale score)
The subject's analgesic treatment satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.
Time frame: 48 hours after the first dose
The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment
The investigator's satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.
Time frame: 48 hours after the first dose