Status:
UNKNOWN
Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Pfizer
Conditions:
Emergence Delirium
Postoperative Pain
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief Summary
This prospective, double blind, placebo-controlled, parallel group study will be conducted in three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing primary electi...
Detailed Description
The inclusion criteria of this study includes: * Aged older than 65; * Primary elective abdominal surgery under general anesthesia; * Ability to understand how to use pain assessment scales and PCA d...
Eligibility Criteria
Inclusion
- Aged older than 65;
- Body weight of at least 50 kg;
- Primary elective abdominal surgery under general anesthesia;
- Preoperative health graded as class ASA I-III, based on medical history and physical examination;
- Ability to understand how to use pain assessment scales and PCA device
Exclusion
- Emergency or revised abdominal surgery;
- History of known use of analgesics or any other agent that could interfere with analgesic responses during the up to 24 h before receipt of the study medication which including NSAIDs, tricyclic antidepressants, neuroleptic or antipsychotic agents, or corticosteroids (except routine preoperative medication);
- History of known or suspected drug abuse;
- Known allergy, sensitivity, or contraindication to opioid and non-opioid analgesic drugs;
- History of bleeding disorders, peptic ulceration, or anticoagulant use within the past month;
- History of asthma or bronchospasm;
- History of inflammatory bowel disease, a chronic or acute renal or hepatic disorder, coronary heart disease;
- History of dementia and psychological disorder;
- Contraindication to parecoxib.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT01221025
Start Date
September 1 2010
End Date
June 1 2012
Last Update
March 25 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080