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

University Hospital, Lille66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interaction Between Antiemetic Drugs and Paracetamol

Interventions

ondansetronDRUG

ondansetron: 4 mg intravenous administration afer the induction of anesthesia.

DroperidolDRUG

droperidol: 1.25 mg intravenous administration after the induction of anesthesia.

DexamethasoneDRUG

dexametasone: 4 mg intravenous administration after the induction of anesthesia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Claude Huriez, CHRU

Lille, France

Outcomes

Primary Outcomes

"electric nociception threshold" measured by PainMatcher

The PainMatcher is a pain self-assessment device using the electric stimulation of the median nerve. The patient maintains a pressure on an electrode box between the thumb and the index finger, creating a current of increasing intensity. The threshold of pain sensation is obtained when the patient releases his fingers from the electrode box. So whe raise the electric nociceptive threshold showned by the PainMatcher. We realize two measures and consider the second one. objective measure.

Time frame: during 2 hours after thyroidectomy in the postoperative care unit

Secondary Outcomes

numeric rating scale score

to evaluate the sensation of pain with a 11 levels going from 0 ( no pain) to 10 ( worst pain imaginable). subjective measure.

Time frame: during 2 hours after thyroidectomy in the postoperative care unit

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

presence of postoperative nausea and vomiting

Time frame: during the 2 hours after thyroidectomy in the postoperative care unit

Data from ClinicalTrials.gov

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