Interaction Between Antiemetic Drugs and Paracetamol
Conditions
Keywords
postoperative analgesia, paracetamol, 5-HT3 antagonist, ondansetron, PainMatcher
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.
Interventions
DRUGondansetron
ondansetron: 4 mg intravenous administration afer the induction of anesthesia.
DRUGDroperidol
droperidol: 1.25 mg intravenous administration after the induction of anesthesia.
DRUGDexamethasone
dexametasone: 4 mg intravenous administration after the induction of anesthesia.
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| electric nociception threshold measured by PainMatcher | during 2 hours after thyroidectomy in the postoperative care unit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| numeric rating scale score | during 2 hours after thyroidectomy in the postoperative care unit | to evaluate the sensation of pain with a 11 levels going from 0 ( no pain) to 10 ( worst pain imaginable). subjective measure. |
| need in rescue analgesia with nefopam in case of numeric rating scale score > 4 | during 2 hours after thyroidectomy in the postoperative care unit | — |
| presence of postoperative nausea and vomiting | during the 2 hours after thyroidectomy in the postoperative care unit | — |
Countries
France
Outcome results
None listed