Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
|ClinicalTrials.gov Identifier: NCT01221025|
Recruitment Status : Unknown
Verified October 2010 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : October 14, 2010
Last Update Posted : March 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Emergence Delirium Postoperative Pain||Drug: Parecoxib||Phase 4|
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 device.
The outcome measures of this study includes:
- Emergence Delirium Assessment;
- Pain intensity and pain relief efficacy endpoints;
- Tolerability and Safety Assessments
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||June 2012|
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
The study group will receive first dose of intravenous (IV) injection of parecoxib sodium 40 mg (in a volume of 2 ml) 60 min before the anticipated end of surgery, followed 2 ml IV injection of parecoxib 40 mg will be occurred at 12, 24 and 36 h after the first dose of parecoxib.
Other Name: Brand name: Dynastat
- emergence agitation [ Time Frame: 45 min after anesthesia ]the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU
- The amount of morphine consumption and Pain intensity [ Time Frame: 48h postoperatively ]The amount of morphine consumption from PCA pump at PACU, 12, 24, 36, and 48h after first dose of study medication; Pain intensity (NRS scores) at 2, 4, 6, 9, 12, 18, 24, 36 and 48 h after the first dose of study medication.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221025
|Contact: Haihua Shu, MD; Ph D||+86-20-87755766 ext email@example.com|
|Contact: Wenqi Huang, MD||+86-20-87755766 ext firstname.lastname@example.org|
|The First Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Haihua Shu, MD; Ph D +86-20-87755766 ext 8273 email@example.com|
|Principal Investigator:||Haihua Shu, MD; Ph D||First Affiliated Hospital, Sun Yat-Sen University|