Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery
Overview
- Phase
- Phase 4
- Sponsor
- Hospital Padre Hurtado
- Enrollment
- 70
- Primary Endpoint
- Maximum pain scores during postoperative period
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: etoricoxib (Drug)
Outcomes
Primary Outcomes
Maximum pain scores during postoperative period
Time Frame: every 6 hours, 24hours,48hours,72hours.
Secondary Outcomes
- Total amount of rescue analgesics(24hours, 48hours, 72hours.)