Trial Outcomes & Findings for Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy (NCT NCT00346268)
NCT ID: NCT00346268
Last Updated: 2011-10-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
24 hours post surgery
Results posted on
2011-10-28
Participant Flow
This study was terminated prematurely due to slow recruitment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Participant refused
|
0
|
3
|
Baseline Characteristics
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Parecoxib and Morphine
n=52 Participants
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.
|
Placebo and Morphine
n=53 Participants
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.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age, Customized
Between 45 and 59 years
|
14 participants
n=93 Participants
|
13 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Age, Customized
Between 60 and 74 years
|
36 participants
n=93 Participants
|
38 participants
n=4 Participants
|
74 participants
n=27 Participants
|
|
Age, Customized
>= 75 years
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hours post surgeryPopulation: Full Analysis Set Population (FAS): participants who were randomized to treatment
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=52 Participants
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.
|
Placebo and Morphine
n=53 Participants
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.
|
|---|---|---|
|
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
|
28.84 mL
Standard Deviation 16.16
|
36.40 mL
Standard Deviation 19.99
|
SECONDARY outcome
Timeframe: 48 hours post surgeryPopulation: FAS
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=52 Participants
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.
|
Placebo and Morphine
n=53 Participants
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.
|
|---|---|---|
|
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
|
42.13 mL
Standard Deviation 25.02
|
57.03 mL
Standard Deviation 28.07
|
SECONDARY outcome
Timeframe: baseline (end of surgery) to 48 hours post surgeryPopulation: FAS; Number of participants analyzed (N)=participants with evaluable data
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Outcome measures
| Measure |
Parecoxib and Morphine
n=48 Participants
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.
|
Placebo and Morphine
n=49 Participants
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.
|
|---|---|---|
|
Time to Last Administration of Morphine
|
46.5 hours
Interval 1.9 to 123.7
|
46.5 hours
Interval 21.8 to 90.3
|
SECONDARY outcome
Timeframe: 48 hours post surgeryPopulation: FAS
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=52 Participants
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.
|
Placebo and Morphine
n=53 Participants
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.
|
|---|---|---|
|
Amount of Blood Loss
|
4.34 g/dL
Standard Deviation 1.40
|
4.41 g/dL
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 48 hours post surgeryPopulation: FAS
Outcome measures
| Measure |
Parecoxib and Morphine
n=52 Participants
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.
|
Placebo and Morphine
n=53 Participants
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.
|
|---|---|---|
|
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
1 RBC transfused unit
|
1 participants
|
1 participants
|
|
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
2 RBC transfused units
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12, 24, 36, and 48 hours post surgeryPopulation: FAS; N=participants with evaluable data
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=51 Participants
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.
|
Placebo and Morphine
n=52 Participants
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.
|
|---|---|---|
|
Pain Intensity Score
At rest, prior to admin, 12 hours post surgery
|
1.31 scores on a scale
Standard Deviation 0.76
|
1.69 scores on a scale
Standard Deviation 0.95
|
|
Pain Intensity Score
At rest, post admin, 12 hours post surgery
|
0.53 scores on a scale
Standard Deviation 0.67
|
0.79 scores on a scale
Standard Deviation 0.78
|
|
Pain Intensity Score
At movement, prior to admin, 12 hours post surgery
|
2.12 scores on a scale
Standard Deviation 0.86
|
2.63 scores on a scale
Standard Deviation 0.95
|
|
Pain Intensity Score
At movement, post admin, 12 hours post surgery
|
1.16 scores on a scale
Standard Deviation 0.88
|
1.58 scores on a scale
Standard Deviation 1.02
|
|
Pain Intensity Score
At rest, prior to admin, 24 hours post surgery
|
1.00 scores on a scale
Standard Deviation 0.82
|
1.44 scores on a scale
Standard Deviation 0.94
|
|
Pain Intensity Score
At rest, post admin, 24 hours post surgery
|
0.53 scores on a scale
Standard Deviation 0.76
|
0.67 scores on a scale
Standard Deviation 0.73
|
|
Pain Intensity Score
At movement, prior to admin, 24 hours post surgery
|
2.12 scores on a scale
Standard Deviation 0.86
|
2.63 scores on a scale
Standard Deviation 0.77
|
|
Pain Intensity Score
At movement, post admin, 24 hours post surgery
|
1.45 scores on a scale
Standard Deviation 1.05
|
1.90 scores on a scale
Standard Deviation 0.96
|
|
Pain Intensity Score
At rest, prior to admin, 36 hours post surgery
|
0.86 scores on a scale
Standard Deviation 0.94
|
1.04 scores on a scale
Standard Deviation 0.87
|
|
Pain Intensity Score
At rest, post admin, 36 hours post surgery
|
0.45 scores on a scale
Standard Deviation 0.61
|
0.59 scores on a scale
Standard Deviation 0.73
|
|
Pain Intensity Score
At movement, prior to admin, 36 hours post surgery
|
1.59 scores on a scale
Standard Deviation 0.98
|
2.12 scores on a scale
Standard Deviation 1.03
|
|
Pain Intensity Score
At movement, post admin, 36 hours post surgery
|
1.04 scores on a scale
Standard Deviation 0.89
|
1.51 scores on a scale
Standard Deviation 0.92
|
|
Pain Intensity Score
At rest, prior to admin, 48 hours post surgery
|
0.67 scores on a scale
Standard Deviation 1.07
|
0.82 scores on a scale
Standard Deviation 0.97
|
|
Pain Intensity Score
At rest, post admin, 48 hours post surgery
|
0.29 scores on a scale
Standard Deviation 0.54
|
0.29 scores on a scale
Standard Deviation 0.58
|
|
Pain Intensity Score
At movement, prior to admin, 48 hours post surgery
|
1.47 scores on a scale
Standard Deviation 1.16
|
2.31 scores on a scale
Standard Deviation 0.97
|
|
Pain Intensity Score
At movement, post admin, 48 hours post surgery
|
0.88 scores on a scale
Standard Deviation 0.86
|
1.41 scores on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 24 and 48 hours post surgeryPopulation: 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.
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).
Outcome measures
| Measure |
Parecoxib and Morphine
n=49 Participants
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.
|
Placebo and Morphine
n=50 Participants
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.
|
|---|---|---|
|
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
|
2.78 scores on a scale
Standard Deviation 1.06
|
|
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
|
2.31 scores on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 24 and 48 hours post surgeryPopulation: FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=49 Participants
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.
|
Placebo and Morphine
n=50 Participants
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.
|
|---|---|---|
|
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
|
1.79 scores on a scale
Standard Deviation 1.50
|
|
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
|
2.32 scores on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: 24 and 48 hours post surgeryPopulation: FAS; N=participants with evaluable data.
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.
Outcome measures
| Measure |
Parecoxib and Morphine
n=51 Participants
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.
|
Placebo and Morphine
n=52 Participants
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.
|
|---|---|---|
|
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
24 hours post surgery
|
0.50 scores on scale
Standard Deviation 0.35
|
0.55 scores on scale
Standard Deviation 0.39
|
|
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
48 hours post surgery
|
0.26 scores on scale
Standard Deviation 0.28
|
0.34 scores on scale
Standard Deviation 0.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 hours post surgeryPopulation: FAS; N=participants with evaluable data.
Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
Outcome measures
| Measure |
Parecoxib and Morphine
n=50 Participants
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.
|
Placebo and Morphine
n=50 Participants
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.
|
|---|---|---|
|
Number of Participants With Rating of Global Evaluation of Study Medication
Poor
|
1 participants
|
3 participants
|
|
Number of Participants With Rating of Global Evaluation of Study Medication
Fair
|
3 participants
|
5 participants
|
|
Number of Participants With Rating of Global Evaluation of Study Medication
Good
|
19 participants
|
31 participants
|
|
Number of Participants With Rating of Global Evaluation of Study Medication
Excellent
|
27 participants
|
11 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 48 hours post surgeryPopulation: Data not analyzed due to study termination.
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".
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 48 hours post surgeryPopulation: Data not analyzed due to study termination.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours post surgeryPopulation: Data not analyzed due to study termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours post surgeryPopulation: Data not analyzed due to study termination.
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.
Outcome measures
Outcome data not reported
Adverse Events
Parecoxib and Morphine
Serious events: 12 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo and Morphine
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Parecoxib and Morphine
n=52 participants at risk
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.
|
Placebo and Morphine
n=53 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infected lymphocele
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
2/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Lymphatic fistula
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Lymphocele
|
7.7%
4/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Parecoxib and Morphine
n=52 participants at risk
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.
|
Placebo and Morphine
n=53 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.5%
6/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.5%
4/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.7%
3/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
13.2%
7/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
4/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.1%
8/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
11.5%
6/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
18.9%
10/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
12/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
30.2%
16/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
17.3%
9/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.5%
4/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.9%
1/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.5%
4/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
11.5%
6/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
13.2%
7/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
3/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
11.5%
6/52
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.5%
4/53
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER