Nausea and Pain Prophylaxis During Thyroid Surgery
Primary Purpose
Thyroid Diseases, Parathyroid Diseases
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
dexamethasone
natriumchloride 0,9%
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Diseases
Eligibility Criteria
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
Sites / Locations
- Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Placebo
dexamethasone "low-dose"
Dexamethasone "high-dose"
Outcomes
Primary Outcome Measures
Pain (VAS) and use of opioids. Nausea.
Secondary Outcome Measures
Nausea
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00569920
Brief Title
Nausea and Pain Prophylaxis During Thyroid Surgery
Official Title
Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sykehuset Telemark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Parathyroid Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
dexamethasone "low-dose"
Arm Title
3
Arm Type
Active Comparator
Arm Description
Dexamethasone "high-dose"
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Fortecortin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
natriumchloride 0,9%
Intervention Description
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
fortecortin
Intervention Description
IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
Primary Outcome Measure Information:
Title
Pain (VAS) and use of opioids. Nausea.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Nausea
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Raeder, Prof. M.D
Organizational Affiliation
Ullevål university hospital, Oslo university
Official's Role
Study Director
Facility Information:
Facility Name
Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital
City
Porsgrunn
State/Province
Telemark
ZIP/Postal Code
3919
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Nausea and Pain Prophylaxis During Thyroid Surgery
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