Etoricoxib for Postoperative Pain After Thyroid Surgery

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

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 Overview

• Status: Unknown
• Conditions: Acute Pain
• Intervention / Treatment: Drug: etoricoxib

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum pain scores during postoperative period	every 6 hours, 24hours,48hours,72hours.

Secondary Outcome Measures

Outcome Measure	Time Frame
Total amount of rescue analgesics	24hours, 48hours, 72hours.

Collaborators and Investigators

• Sponsor: Hospital Padre Hurtado

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2010
• Study Completion (ANTICIPATED): September 1, 2010

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (ESTIMATE): July 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2009
• Last Update Submitted That Met QC Criteria: July 7, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: AR001cl