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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00569920
Other study ID # s8197.04
Secondary ID S-04189
Status Completed
Phase N/A
First received December 7, 2007
Last updated January 14, 2009
Start date September 2007
Est. completion date December 2008

Study information

Verified date January 2009
Source Sykehuset Telemark
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).
natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
dexamethasone
IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.

Locations

Country Name City State
Norway Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital Porsgrunn Telemark

Sponsors (1)

Lead Sponsor Collaborator
Sykehuset Telemark

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain (VAS) and use of opioids. Nausea. 30 days No
Secondary Nausea 30 days No
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