Etoricoxib for Postoperative Pain After Thyroid Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

etoricoxib

Intervention Type 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

Interventions

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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 Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No