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Etoricoxib for Postoperative Pain After Thyroid Surgery

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ClinicalTrials.gov Identifier: NCT00935116
Recruitment Status : Unknown
Verified July 2009 by Hospital Padre Hurtado.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
Hospital Padre Hurtado

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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: etoricoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery
Study Start Date : July 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

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





Primary Outcome Measures :
  1. Maximum pain scores during postoperative period [ Time Frame: every 6 hours, 24hours,48hours,72hours. ]

Secondary Outcome Measures :
  1. Total amount of rescue analgesics [ Time Frame: 24hours, 48hours, 72hours. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Alejandro Recart, MD, Padre Hurtado General Hospital
ClinicalTrials.gov Identifier: NCT00935116    
Other Study ID Numbers: AR001cl
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action