Clinical trial NCT01679093: Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.
Official title: Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Interaction Between Antiemetic Drugs and Paracetamol
Keywords: postoperative analgesia
paracetamol
5-HT3 antagonist
ondansetron
PainMatcher
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to determine if there is an antagonism between drugs used in the prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen after thyroidectomy.

Detailed description: It was shown that there was an antagonism of the ondansetron on the analgesia led by acetaminophen in a model of nociception by electrical stimulation using the PainMatcher in healthy volunteers. Our study try to determinate if a such antagonism exist in clinical conditions : 66 patients with an Apfel-score II undergoing thyroidectomy were randomized in 3 equal groups. Each group received an antiemetic (ondansetron, droperidol or dexamethasone) at the begining of the intervention and paracetamol at the end of the intervention for the postoperative analgesia. During 2 hours in the postoperative unit, we raised : the electrical pain's threshold with the PainMatcher, the numeric pain intensity scale and the presence of nausea or vomiting. For each patients we determined the cytochrome P450 2D6 activity that should have been able to explain a diminution of ondansetron's efficiency. Paracetamol blood levels were also raised in the postoperative unit.

Eligibility 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

Primary outcomes:
measure: "electric nociception threshold" measured by PainMatcher
timeFrame: during 2 hours after thyroidectomy in the postoperative care unit
Secondary outcomes:
measure: numeric rating scale score
timeFrame: during 2 hours after thyroidectomy in the postoperative care unit
measure: need in rescue analgesia with nefopam in case of numeric rating scale score > 4
timeFrame: during 2 hours after thyroidectomy in the postoperative care unit
measure: presence of postoperative nausea and vomiting
timeFrame: during the 2 hours after thyroidectomy in the postoperative care unit
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU
Study officials:
affiliation: University hospital of Lille
name: Gilles Lebuffe, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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