Etoricoxib for Postoperative Pain After Thyroid Surgery

Acute Pain Clinical Trial

Official title:

Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00935116
• Other study ID #: AR001cl
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: July 7, 2009
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2009
• Source: Hospital Padre Hurtado
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2 specific analgesic Etoricoxib (arcoxia®) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up in the immediate postoperative period, during the first postoperative (POD) day and in POD 2, 3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age >18 and <70 years

• body weight within normal ranges

• ability to understand the use of pain assessment scales and the PCA device

Exclusion Criteria:

• known allergy to any of the drugs utilized

• contraindication to opioid and non-opioid analgesic drugs

• a history of bleeding disorders, peptic ulceration or anticoagulant use within the last month

• pregnant or breast-feeding patients

• history of known or suspected drug abuse or patients who had taken NSAIDs within 24 h prior to surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Intervention

Drug:
• etoricoxib
G1 (CONTROL): Oral NSAID (diclofenac, three times a day) administrated pre-operatively and for 3 days after surgery. G2: Etoricoxib 120 mg, pre and post-operatively for 3 days after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Padre Hurtado

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain scores during postoperative period		every 6 hours, 24hours,48hours,72hours.	No
Secondary	Total amount of rescue analgesics		24hours, 48hours, 72hours.	No