Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT01679093
• Date of registration: 31/08/2012
• Prospective Registration: No
• Primary sponsor: University Hospital, Lille
• Public title: Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia. ANPATHY
• Scientific title: Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.
• Date of first enrolment: June 2009
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01679093
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Gilles Lebuffe, MD,PhD
• Affiliation: University hospital of Lille

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients undergoing thyroidectomy without lymph node dissection

- American Society of Anesthesiologists physical status from I to III

- Apfel-score equal to 2

- informed consent signed

Exclusion Criteria:

- pregnant and breast-feeding women

- addictive disorders

- psychic diseases

- allergy or contra-indication to a drug used in the study

- presence of postoperative nausea or vomiting

- administration of glucocorticoid for protecting recurrent laryngeal nerve.

- protocol not respected

- protocol refused by the patient

- intellectual handicap



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Interaction Between Antiemetic Drugs and Paracetamol

Intervention(s)

Drug: Dexamethasone

Drug: ondansetron

Drug: Droperidol

Primary Outcome(s)

"electric nociception threshold" measured by PainMatcher [Time Frame: during 2 hours after thyroidectomy in the postoperative care unit]

Secondary Outcome(s)

need in rescue analgesia with nefopam in case of numeric rating scale score > 4 [Time Frame: during 2 hours after thyroidectomy in the postoperative care unit]

numeric rating scale score [Time Frame: during 2 hours after thyroidectomy in the postoperative care unit]

presence of postoperative nausea and vomiting [Time Frame: during the 2 hours after thyroidectomy in the postoperative care unit]

Secondary ID(s)

2008-002701-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors