Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|