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Completed

NCT Number: NCT00569920

Nausea and Pain Prophylaxis During Thyroid Surgery

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.

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Key information

Conditions

Thyroid Diseases Endocrine System Diseases Parathyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital

Porsgrunn, Telemark, 3919, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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 names: Fortecortin

natriumchloride 0,9%

Drug

iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.

Primary outcomes

  1. Pain (VAS) and use of opioids. Nausea.

    Time frame: 30 days

Secondary outcomes

  1. Nausea

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 10, 2007
Registry last updated
Jan 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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