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Nausea and Pain Prophylaxis During Thyroid Surgery

This study has been completed.
Sponsor:
Information provided by:
Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00569920
First received: December 7, 2007
Last updated: January 14, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Thyroid Diseases
Parathyroid Diseases
 Drug: dexamethasone
Drug: natriumchloride 0,9%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Pain (VAS) and use of opioids. Nausea. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nausea [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: natriumchloride 0,9%
iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Active Comparator: 2
dexamethasone "low-dose"
 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).
Other Name: Fortecortin
Active Comparator: 3
Dexamethasone "high-dose"
 Drug: dexamethasone
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569920

Locations
Norway
Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital
Porsgrunn, Telemark, Norway, 3919
Sponsors and Collaborators
Sykehuset Telemark
Investigators
Study Director: Johan Raeder, Prof. M.D Ullevål university hospital, Oslo university
  More Information

No publications provided

Responsible Party: Simen Doksrød/Acting chief physician, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00569920     History of Changes
Other Study ID Numbers: s8197.04, S-04189
Study First Received: December 7, 2007
Last Updated: January 14, 2009
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Parathyroid Diseases
Thyroid Diseases
Endocrine System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013