Pain
Conditions
Brief summary
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
Detailed description
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.
Interventions
A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
DRUGPlacebo
A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery * American Society of Anaesthesiologists (ASA) Physical Status I-III
Exclusion criteria
* Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results * Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Health Outcomes Recovery Questionnaire on Days 2, 3, and 4. | 4 days |
| Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4. | 4 days |
| Length of stay on Day 1. | 1 day |
| Patient Satisfaction Questionnaire on Days 1 and 4. | 4 days |
| Evaluation of unplanned hospital admissions on Day 4. | 4 days |
| Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4. | 4 days |
| Modified Brief Pain Inventory on Days 2, 3, and 4. | 4 days |
| Readiness for discharge on Day 1. | 1 day |
| Quality of Recovery Score on Days 1, 2, and 3. | 3 days |
Countries
Australia
Outcome results
None listed