Pain, Postoperative
Conditions
Brief summary
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
Detailed description
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.
Interventions
DRUGMorphine, Parecoxib
Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
DRUGMorphine, Placebo
Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,\<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator. * The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Exclusion criteria
* The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results * The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery | 24 hours post surgery | Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Blood Loss | 48 hours post surgery | Calculated as: (\[Hb g/dL\]pra + RBCUduring48)-\[Hb g/dL\]at 48, where \[Hb g/dL\]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), \[Hb g/dL\]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure. |
| Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 48 hours post surgery | — |
| Pain Intensity Score | 12, 24, 36, and 48 hours post surgery | Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity). Movement defined as sitting up from a lying into a sitting position in bed. |
| Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score | 24 and 48 hours post surgery | mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now). |
| Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score | 24 and 48 hours post surgery | mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours. |
| Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score | 24 and 48 hours post surgery | Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4. |
| Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery | 48 hours post surgery | Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy. |
| Time to Last Administration of Morphine | baseline (end of surgery) to 48 hours post surgery | Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Analgesic Benefit Score (OABS) | 24 and 48 hours post surgery | Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24. |
| Hemoglobin Concentration | 24 hours post surgery | — |
| Total Amount of Postoperative Drainage Fluid | 24 hours post surgery | After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured. |
| Number of Participants With Rating of Global Evaluation of Study Medication | 48 hours post surgery | Participants asked, How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent. |
| Number of Participants With Health Care Resource Utilization (HCRU) | 24 and 48 hours post surgery | Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist. |
Countries
Germany
Participant flow
Recruitment details
This study was terminated prematurely due to slow recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Parecoxib and Morphine Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. | 52 |
| Placebo and Morphine Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. | 53 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Participant refused | 0 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Parecoxib and Morphine | Placebo and Morphine | Total |
|---|---|---|---|
| Age, Customized < 45 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >= 75 years | 2 participants | 2 participants | 4 participants |
| Age, Customized Between 45 and 59 years | 14 participants | 13 participants | 27 participants |
| Age, Customized Between 60 and 74 years | 36 participants | 38 participants | 74 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 52 Participants | 53 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 52 | 38 / 53 |
| serious Total, serious adverse events | 12 / 52 | 5 / 53 |
Outcome results
Primary
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
Time frame: 24 hours post surgery
Population: Full Analysis Set Population (FAS): participants who were randomized to treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib and Morphine | Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery | 28.84 mL | Standard Deviation 16.16 |
| Placebo and Morphine | Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery | 36.40 mL | Standard Deviation 19.99 |
p-value: 0.03595% CI: [-14.63, -0.53]ANOVA
Secondary
Amount of Blood Loss
Calculated as: (\[Hb g/dL\]pra + RBCUduring48)-\[Hb g/dL\]at 48, where \[Hb g/dL\]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), \[Hb g/dL\]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.
Time frame: 48 hours post surgery
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib and Morphine | Amount of Blood Loss | 4.34 g/dL | Standard Deviation 1.4 |
| Placebo and Morphine | Amount of Blood Loss | 4.41 g/dL | Standard Deviation 2.12 |
p-value: 0.8195% CI: [-0.68, 0.53]ANCOVA
Secondary
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.
Time frame: 48 hours post surgery
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parecoxib and Morphine | Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery | 42.13 mL | Standard Deviation 25.02 |
| Placebo and Morphine | Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery | 57.03 mL | Standard Deviation 28.07 |
p-value: 0.00495% CI: [-25.47, -4.85]ANOVA
Secondary
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.
Time frame: 24 and 48 hours post surgery
Population: FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score | 24 hours post surgery (n=49, 50) | 1.16 scores on a scale | Standard Deviation 1.21 |
| Parecoxib and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score | 48 hours post surgery (n=43, 48) | 1.00 scores on a scale | Standard Deviation 1.41 |
| Placebo and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score | 24 hours post surgery (n=49, 50) | 2.32 scores on a scale | Standard Deviation 1.78 |
| Placebo and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score | 48 hours post surgery (n=43, 48) | 1.79 scores on a scale | Standard Deviation 1.5 |
Comparison: 24 hours post surgeryp-value: 0.00195% CI: [-1.77, -0.56]ANOVA
Comparison: 48 hours post surgeryp-value: 0.00695% CI: [-1.41, -0.24]ANOVA
Secondary
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).
Time frame: 24 and 48 hours post surgery
Population: FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score | 24 hours post surgery (n=49, 50) | 2.08 scores on a scale | Standard Deviation 1.17 |
| Parecoxib and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score | 48 hours post surgery (n=43, 48) | 1.60 scores on a scale | Standard Deviation 1.26 |
| Placebo and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score | 24 hours post surgery (n=49, 50) | 2.78 scores on a scale | Standard Deviation 1.06 |
| Placebo and Morphine | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score | 48 hours post surgery (n=43, 48) | 2.31 scores on a scale | Standard Deviation 1.17 |
Comparison: 24 hours post surgeryp-value: 0.00295% CI: [-1.16, -0.26]ANOVA
Comparison: 48 hours post surgeryp-value: 0.00495% CI: [-1.22, -0.23]ANOVA
Secondary
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Time frame: 48 hours post surgery
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parecoxib and Morphine | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 1 RBC transfused unit | 1 participants |
| Parecoxib and Morphine | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 2 RBC transfused units | 4 participants |
| Placebo and Morphine | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 1 RBC transfused unit | 1 participants |
| Placebo and Morphine | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 2 RBC transfused units | 1 participants |
Secondary
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.
Time frame: 24 and 48 hours post surgery
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib and Morphine | Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score | 24 hours post surgery | 0.50 scores on scale | Standard Deviation 0.35 |
| Parecoxib and Morphine | Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score | 48 hours post surgery | 0.26 scores on scale | Standard Deviation 0.28 |
| Placebo and Morphine | Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score | 48 hours post surgery | 0.34 scores on scale | Standard Deviation 0.34 |
| Placebo and Morphine | Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score | 24 hours post surgery | 0.55 scores on scale | Standard Deviation 0.39 |
Secondary
Pain Intensity Score
Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity). Movement defined as sitting up from a lying into a sitting position in bed.
Time frame: 12, 24, 36, and 48 hours post surgery
Population: FAS; N=participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parecoxib and Morphine | Pain Intensity Score | At movement, prior to admin, 24 hours post surgery | 2.12 scores on a scale | Standard Deviation 0.86 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, post admin, 12 hours post surgery | 0.53 scores on a scale | Standard Deviation 0.67 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, post admin, 12 hours post surgery | 1.16 scores on a scale | Standard Deviation 0.88 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, prior to admin, 12 hours post surgery | 2.12 scores on a scale | Standard Deviation 0.86 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, post admin, 24 hours post surgery | 1.45 scores on a scale | Standard Deviation 1.05 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, prior to admin, 36 hours post surgery | 1.59 scores on a scale | Standard Deviation 0.98 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, post admin, 24 hours post surgery | 0.53 scores on a scale | Standard Deviation 0.76 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, post admin, 36 hours post surgery | 1.04 scores on a scale | Standard Deviation 0.89 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, prior to admin, 36 hours post surgery | 0.86 scores on a scale | Standard Deviation 0.94 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, prior to admin, 48 hours post surgery | 0.67 scores on a scale | Standard Deviation 1.07 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, prior to admin, 24 hours post surgery | 1.00 scores on a scale | Standard Deviation 0.82 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, post admin, 48 hours post surgery | 0.29 scores on a scale | Standard Deviation 0.54 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, post admin, 36 hours post surgery | 0.45 scores on a scale | Standard Deviation 0.61 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, prior to admin, 48 hours post surgery | 1.47 scores on a scale | Standard Deviation 1.16 |
| Parecoxib and Morphine | Pain Intensity Score | At movement, post admin, 48 hours post surgery | 0.88 scores on a scale | Standard Deviation 0.86 |
| Parecoxib and Morphine | Pain Intensity Score | At rest, prior to admin, 12 hours post surgery | 1.31 scores on a scale | Standard Deviation 0.76 |
| Placebo and Morphine | Pain Intensity Score | At movement, post admin, 48 hours post surgery | 1.41 scores on a scale | Standard Deviation 0.98 |
| Placebo and Morphine | Pain Intensity Score | At movement, post admin, 12 hours post surgery | 1.58 scores on a scale | Standard Deviation 1.02 |
| Placebo and Morphine | Pain Intensity Score | At rest, prior to admin, 24 hours post surgery | 1.44 scores on a scale | Standard Deviation 0.94 |
| Placebo and Morphine | Pain Intensity Score | At rest, post admin, 24 hours post surgery | 0.67 scores on a scale | Standard Deviation 0.73 |
| Placebo and Morphine | Pain Intensity Score | At movement, prior to admin, 24 hours post surgery | 2.63 scores on a scale | Standard Deviation 0.77 |
| Placebo and Morphine | Pain Intensity Score | At movement, post admin, 24 hours post surgery | 1.90 scores on a scale | Standard Deviation 0.96 |
| Placebo and Morphine | Pain Intensity Score | At rest, prior to admin, 36 hours post surgery | 1.04 scores on a scale | Standard Deviation 0.87 |
| Placebo and Morphine | Pain Intensity Score | At rest, prior to admin, 12 hours post surgery | 1.69 scores on a scale | Standard Deviation 0.95 |
| Placebo and Morphine | Pain Intensity Score | At rest, post admin, 12 hours post surgery | 0.79 scores on a scale | Standard Deviation 0.78 |
| Placebo and Morphine | Pain Intensity Score | At rest, post admin, 36 hours post surgery | 0.59 scores on a scale | Standard Deviation 0.73 |
| Placebo and Morphine | Pain Intensity Score | At movement, prior to admin, 36 hours post surgery | 2.12 scores on a scale | Standard Deviation 1.03 |
| Placebo and Morphine | Pain Intensity Score | At movement, post admin, 36 hours post surgery | 1.51 scores on a scale | Standard Deviation 0.92 |
| Placebo and Morphine | Pain Intensity Score | At rest, prior to admin, 48 hours post surgery | 0.82 scores on a scale | Standard Deviation 0.97 |
| Placebo and Morphine | Pain Intensity Score | At rest, post admin, 48 hours post surgery | 0.29 scores on a scale | Standard Deviation 0.58 |
| Placebo and Morphine | Pain Intensity Score | At movement, prior to admin, 48 hours post surgery | 2.31 scores on a scale | Standard Deviation 0.97 |
| Placebo and Morphine | Pain Intensity Score | At movement, prior to admin, 12 hours post surgery | 2.63 scores on a scale | Standard Deviation 0.95 |
Comparison: The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.p-value: 0.0795% CI: [-0.01, 0.35]ANOVA
Comparison: The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.p-value: 0.07495% CI: [-0.02, 0.33]ANOVA
Secondary
Time to Last Administration of Morphine
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Time frame: baseline (end of surgery) to 48 hours post surgery
Population: FAS; Number of participants analyzed (N)=participants with evaluable data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Parecoxib and Morphine | Time to Last Administration of Morphine | 46.5 hours |
| Placebo and Morphine | Time to Last Administration of Morphine | 46.5 hours |
p-value: 0.257Log Rank
Other Pre-specified
Hemoglobin Concentration
Time frame: 24 hours post surgery
Population: Data not analyzed due to study termination.
Other Pre-specified
Number of Participants With Health Care Resource Utilization (HCRU)
Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist.
Time frame: 24 and 48 hours post surgery
Population: Data not analyzed due to study termination.
Other Pre-specified
Number of Participants With Rating of Global Evaluation of Study Medication
Participants asked, How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent.
Time frame: 48 hours post surgery
Population: FAS; N=participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parecoxib and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Poor | 1 participants |
| Parecoxib and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Fair | 3 participants |
| Parecoxib and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Good | 19 participants |
| Parecoxib and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Excellent | 27 participants |
| Placebo and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Excellent | 11 participants |
| Placebo and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Poor | 3 participants |
| Placebo and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Good | 31 participants |
| Placebo and Morphine | Number of Participants With Rating of Global Evaluation of Study Medication | Fair | 5 participants |
Other Pre-specified
Overall Analgesic Benefit Score (OABS)
Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.
Time frame: 24 and 48 hours post surgery
Population: Data not analyzed due to study termination.
Other Pre-specified
Total Amount of Postoperative Drainage Fluid
After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.
Time frame: 24 hours post surgery
Population: Data not analyzed due to study termination.