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Completed

NCT Number: NCT01679093

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

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.

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Key information

Conditions

Interaction Between Antiemetic Drugs and Paracetamol

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Claude Huriez, CHRU

Lille, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

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

Droperidol

Drug

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

Dexamethasone

Drug

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

Primary outcomes

  1. "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.

    objective measure.

Secondary outcomes

  1. 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).

    subjective measure.

  2. 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

  3. presence of postoperative nausea and vomiting

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

Acronym: ANPATHY

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 5, 2012
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.