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Etoricoxib for Postoperative Pain After Thyroid Surgery

Primary Purpose

Acute Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
etoricoxib
Sponsored by
Hospital Padre Hurtado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    etoricoxib

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Maximum pain scores during postoperative period

    Secondary Outcome Measures

    Total amount of rescue analgesics

    Full Information

    First Posted
    July 7, 2009
    Last Updated
    July 7, 2009
    Sponsor
    Hospital Padre Hurtado
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00935116
    Brief Title
    Etoricoxib for Postoperative Pain After Thyroid Surgery
    Official Title
    Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    September 2010 (Anticipated)
    Study Completion Date
    September 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Padre Hurtado

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    etoricoxib
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Name(s)
    etoricoxib
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Maximum pain scores during postoperative period
    Time Frame
    every 6 hours, 24hours,48hours,72hours.
    Secondary Outcome Measure Information:
    Title
    Total amount of rescue analgesics
    Time Frame
    24hours, 48hours, 72hours.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Etoricoxib for Postoperative Pain After Thyroid Surgery

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