Nausea and Pain Prophylaxis During Thyroid Surgery

This study has been completed.
Sponsor:
Information provided by:
Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00569920
First received: December 7, 2007
Last updated: January 14, 2009
Last verified: January 2009

December 7, 2007
January 14, 2009
September 2007
December 2008   (final data collection date for primary outcome measure)
Pain (VAS) and use of opioids. Nausea. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00569920 on ClinicalTrials.gov Archive Site
Nausea [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nausea and Pain Prophylaxis During Thyroid Surgery
Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Thyroid Diseases
  • Parathyroid Diseases
  • 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
  • Drug: natriumchloride 0,9%
    iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
  • 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
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: natriumchloride 0,9%
  • Active Comparator: 2
    dexamethasone "low-dose"
    Intervention: Drug: dexamethasone
  • Active Comparator: 3
    Dexamethasone "high-dose"
    Intervention: Drug: dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00569920
s8197.04, S-04189
Yes
Simen Doksrød/Acting chief physician, Sykehuset Telemark
Sykehuset Telemark
Not Provided
Study Director: Johan Raeder, Prof. M.D Ullevål university hospital, Oslo university
Sykehuset Telemark
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP