Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia. (ANPATHY)
|ClinicalTrials.gov Identifier: NCT01679093|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Interaction Between Antiemetic Drugs and Paracetamol||Drug: ondansetron Drug: Droperidol Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||June 2011|
Active Comparator: ONDANSETRON (OS)
patients receiving ondansetron at the beginning of the surgery to prevent postoperative nausea and vomiting (PONV); and paracetamol at the end of the surgery for postoperative analgesia.
ondansetron: 4 mg intravenous administration afer the induction of anesthesia.
Active Comparator: DROPERIDOL (DRO)
patients receiving droperidol at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
droperidol: 1.25 mg intravenous administration after the induction of anesthesia.
Active Comparator: DEXAMETHASONE (DEXA)
patients receiving dexamethasone at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.
dexametasone: 4 mg intravenous administration after the induction of anesthesia.
- "electric nociception threshold" measured by PainMatcher [ Time Frame: 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.
- numeric rating scale score [ Time Frame: 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).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679093
|Hôpital Claude Huriez, CHRU|
|Lille, France, 59000|
|Principal Investigator:||Gilles Lebuffe, MD,PhD||University hospital of Lille|