Etoricoxib for Postoperative Pain After Thyroid Surgery

NCT00935116 | Unknown Phase 4

• 1 other identifier: AR001cl
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Maximum pain scores during postoperative period

  every 6 hours, 24hours,48hours,72hours.

Secondary Outcomes (1)

• Total amount of rescue analgesics

  24hours, 48hours, 72hours.

Study Arms (1)

etoricoxib

ACTIVE COMPARATOR

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

Interventions

etoricoxib DRUG

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

etoricoxib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 and \<70 years
• body weight within normal ranges
• ability to understand the use of pain assessment scales and the PCA device

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Padre Hurtado: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 8, 2009

Record last verified: 2009-07