The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Usage of Morphine, Post Surgery
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.
Time frame: 0 hour to 24 hours after IP administration
Usage of Morphine, Post Surgery at other intervals
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.
Time frame: 0 hour to 48 hours after IP administration
Pain intensity assessed using an 11-point NRS ranging
11-point NPRS ranging from a score of 0 to 10.
Time frame: Baseline till 48 hours post IP administration
Pain relief assessed using an 5-point likert scale
5-point likert scale from a score of 0 to 4.
Time frame: Baseline till 48 hours post IP administration
Time to First Dose of Rescue Analgesia
Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Time frame: 0 hour to 48 hours after IP administration
Frequency of Doses of Rescue Analgesia Utilized Per Subject
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
Time frame: 0 hour to 48 hours after IP administration
Proportion of subjects who received Rescue Analgesia
Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
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Time frame: 0 hour to 48 hours after IP administration
Patient Global Assessment (PGA) of Pain Control
PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)
Time frame: 0 hour to 48 hours after IP administration