The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bad as you can image at resting stage
Time frame: Baseline and 6h (±20min)
VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison
Time frame: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
The Use of Rescue Analgesics During the 24-hour Observation Period
To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison
Time frame: 24 hours after the first dose.
VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage
Time frame: Baseline and 6h (±20min)
Sleeping Quality Assessment
To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison Sleeping quality scale 1. Very Good 2. Good 3. Fair 4. Bad 5. Very Bad
Time frame: 24 hours after administration of first dose
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Satisfaction With Pain Control
To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison 1. Very Satisfied 2. Satisfied 3. Fair 4. Not Satisfied 5. Not Satisfied at all
Time frame: 24 hours after administration of first dose
Comparison of the Total Amount of Study Drugs Used During the 24 Hours
To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.
Time frame: 24 hours after administration of first dose