Nausea and Pain Prophylaxis During Thyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid Diseases; Parathyroid Diseases
• Interventions: Drug: natriumchloride 0,9%; Drug: dexamethasone

• Registration Number: NCT00569920
• Lead Sponsor: Sykehuset Telemark

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-14
• Last Update Posted: 2009-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia.
• Informed consent

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Exclusion Criteria

• Patients who use steroids
• Patients who use antiemetics
• Patients who use opioid analgesics
• Body weight > 100 kg
• BMI > 35

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	natriumchloride 0,9%	Placebo
2	dexamethasone	dexamethasone "low-dose"
3	dexamethasone	Dexamethasone "high-dose"

Primary Outcome Measures

Name	Time	Method
Pain (VAS) and use of opioids. Nausea.	30 days

Secondary Outcome Measures

Name	Time	Method
Nausea	30 days

Trial Locations

Locations (1)

Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital; 🇳🇴 Porsgrunn, Telemark, Norway