Comparison between the analgesics ketoprofen and parecoxib for pain control after gallbladder surgical removal

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-249vpp
• Date of registration: 13/02/2012
• Primary sponsor: Pontifícia Universidade Católica de Campinas - PUCCAMP - Brazil
• Public title: Comparison between the analgesics ketoprofen and parecoxib for pain control after gallbladder surgical removal
• Scientific title: Postoperative analgesia: comparison between ketoprofen and parecoxib in patients submitted to conventional cholecystectomy
• Date of first enrolment: 10/01/2010
• Target sample size: 55
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-249vpp/
• Study design: Dual-arm clinical trial, randomized, double-blind, phase 4.

Countries of recruitment

Brazil

Contacts

• Name: Jose Orosz
• Affiliation: PUCCAMP

• Name: Jose Orosz
• Affiliation: PUCCAMP

Key inclusion & exclusion criteria

Inclusion criteria: Physical status ASA 1 or 2 patients, undergoing conventional cholecystectomy, of both genders, aged 18 to 55 years old.
Exclusion criteria: ASA Physical Status 3, 4 or 5.
Patients using hormonal or nonhormonal anti-inflammatory drugs.

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

Post operative pain
C10.597.617

Intervention(s)

This prospective double blind study will include 55 physical status ASA 1 or 2 patients, undergoing conventional cholecystectomy, of both genders, aged 18 to 55 years old, allocated in a random and covert way in the groups: C - which will receive IV ketoprofen at a dose of 100 mg and P - which will receive parecoxib 40 mg IV dose. Patients from both groups will be submitted to total intravenous general anesthesia, induced with sufentanil 1 mcg/kg, cis-atracurium 0.15 mg/kg and propofol 3 mg/kg, and maintained with remifentanil 0.1 mcg/kg/min and propofol 3mg/kg/h . In the postoperative period patients will be assessed for the presence of pain on arrival to the post-anesthesia care unit (PACU), and after 1, 2, 4, 6 and 12 hours, using the analog pain scale (APS). Possible need for additional analgesia will be made with 1mg/kg tramadol IV and dipyrone 2g IV and also analyzed.

Primary Outcome(s)

Cholecystectomy

Secondary Outcome(s)

Postoperative pain, assessed by the patient via analog scale of pain.

Secondary ID(s)

144604

757/08

Source(s) of Monetary Support

Pontifícia Universidade Católica de Campinas - PUCCAMP - Brazil

Secondary Sponsor(s)

Pontifícia Universidade Católica de Campinas - PUCCAMP - Brazil