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Completed

NCT Number: NCT00520338

Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

The purpose of this study is to determine whether celecoxib is effective in the treatment postoperative pain after thyroidectomy.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib or placebo.

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Key information

Conditions

Postoperative Pain Cyclooxygenase 2 Inhibitors Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

Postoperative pain has been concerned in the past few years by both the anesthesiologists ans the surgeons. COX2-inhibitors have played an important roles in postoperative pain with minimal side effects.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib and placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ASA physical status I-III.
  • Scheduled for an elective thyroidectomy.
  • Body weight > or = 40kg
  • Can operate a patient-controlled analgesia (PCA) device.

Exclusion criteria

  • History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  • Known hypersensitivity to morphine or sulfonamides.
  • History of hepatic dysfunction.
  • Creatinine clearance < 30ml/min.
  • History of bleeding tendency.
  • History of gastrointestinal bleeding or active peptic ulcer.
  • Known case of inflammatory bowel disease.
  • Patient with severe heart failure.

Treatment and study plan

Celecoxib

Drug
  • placebo
  • celecoxib 400 mg oral single dose

Other names: celebrex

Primary outcomes

  1. The patients' total amount of morphine requirement in the first 24 hour.

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 24, 2007
Registry last updated
Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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