Nausea and Pain Prophylaxis During Thyroid Surgery

Thyroid Diseases Clinical Trial

Official title:

Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo

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

• Parathyroid Diseases
• Thyroid Diseases

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