Nausea and Pain Prophylaxis During Thyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569920
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : January 15, 2009
Information provided by:
Sykehuset Telemark

Brief Summary:

Postoperative pain and nausea may diminish a patient`s wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. Opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing patients` postoperative need for opioids have been well-documented.

One non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. In our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery.

Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile.

Condition or disease Intervention/treatment Phase
Thyroid Diseases Parathyroid Diseases Drug: dexamethasone Drug: natriumchloride 0,9% Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo
Study Start Date : September 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Drug: natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Active Comparator: 2
dexamethasone "low-dose"
Drug: dexamethasone
IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).
Other Name: Fortecortin
Active Comparator: 3
Dexamethasone "high-dose"
Drug: dexamethasone
IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
Other Name: fortecortin

Primary Outcome Measures :
  1. Pain (VAS) and use of opioids. Nausea. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Nausea [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia.
  • Informed consent

Exclusion Criteria:

  • Patients who use steroids
  • Patients who use antiemetics
  • Patients who use opioid analgesics
  • Body weight > 100 kg
  • BMI > 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569920

Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital
Porsgrunn, Telemark, Norway, 3919
Sponsors and Collaborators
Sykehuset Telemark
Study Director: Johan Raeder, Prof. M.D Ullevål university hospital, Oslo university

Responsible Party: Simen Doksrød/Acting chief physician, Sykehuset Telemark Identifier: NCT00569920     History of Changes
Other Study ID Numbers: s8197.04
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action