This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
single dose+PCA dose
single dose+PCA dose
single dose+PCA dose
241 Huaihai West Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, China
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Time frame: during the first 24 hours after starting a loading dose of test drug infusion
Resting-state pain and exercise-state pain intensity
Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion
"exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
total pain relief (TOTPAR) scores
Time-weighted sum of resting and moving state pain relief scores
Time frame: 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
the percentage of patients receiving rescue analgesia
the percentage of patients receiving rescue analgesia
Time frame: from 0-24 hours after the first loading dose
length of bed stay
length out of bed
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
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Length of hospital stay
postoperative length of hospital stay
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
incidence of Postoperative nausea and vomiting
incidence rate of PONV
Time frame: the first 24 hours after surgery
incidence rate of respiratory depression
respiratory depression is defined as respiratory rate \< 8 and/or SpO2\<90%
Time frame: the first 24 hours after surgery
analgesia satisfaction
satisfaction evaluation using 0-100 scale
Time frame: the first 24 hours after surgery
pressing times of postoperative analgesic pump
Time frame: the first 24 hours after surgery
total doses of postoperative analgesic pump
Time frame: the first 24 hours after surgery