Nausea and Pain Prophylaxis During Thyroid Surgery
|ClinicalTrials.gov Identifier: NCT00569920|
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : January 15, 2009
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Placebo Comparator: 1
Drug: natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Active Comparator: 2
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
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
- Pain (VAS) and use of opioids. Nausea. [ Time Frame: 30 days ]
- Nausea [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569920
|Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital|
|Porsgrunn, Telemark, Norway, 3919|
|Study Director:||Johan Raeder, Prof. M.D||Ullevål university hospital, Oslo university|