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

NCT01679093 | Completed Phase 3 DMC

• 1 other identifier: 2008-002701-40
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Interaction Between Antiemetic Drugs and Paracetamol

Keywords

postoperative analgesia; paracetamol; 5-HT3 antagonist; ondansetron; PainMatcher

Outcome Measures

Primary Outcomes (1)

• "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.

  during 2 hours after thyroidectomy in the postoperative care unit

Secondary Outcomes (3)

• numeric rating scale score

  during 2 hours after thyroidectomy in the postoperative care unit

• 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

Study Arms (3)

ONDANSETRON (OS)

ACTIVE COMPARATOR

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.

Drug: ondansetron

DROPERIDOL (DRO)

ACTIVE COMPARATOR

patients receiving droperidol at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.

Drug: Droperidol

DEXAMETHASONE (DEXA)

ACTIVE COMPARATOR

patients receiving dexamethasone at the beginning of the surgery to prevent PONV; and paracetamol at the end of the surgey for postoperative analgesia.

Drug: Dexamethasone

Interventions

ondansetron DRUG

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

ONDANSETRON (OS)

Droperidol DRUG

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

DROPERIDOL (DRO)

Dexamethasone DRUG

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

DEXAMETHASONE (DEXA)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Claude Huriez, CHRU

Lille, 59000, France

Location

Related Publications (19)

• Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.

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• Girard P, Pansart Y, Coppe MC, Niedergang B, Gillardin JM. Modulation of paracetamol and nefopam antinociception by serotonin 5-HT(3) receptor antagonists in mice. Pharmacology. 2009;83(4):243-6. doi: 10.1159/000207448. Epub 2009 Mar 9.

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• Courade JP, Chassaing C, Bardin L, Alloui A, Eschalier A. 5-HT receptor subtypes involved in the spinal antinociceptive effect of acetaminophen in rats. Eur J Pharmacol. 2001 Nov 30;432(1):1-7. doi: 10.1016/s0014-2999(01)01464-9.

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  PMID: 18782884 BACKGROUND

• Candiotti KA, Birnbach DJ, Lubarsky DA, Nhuch F, Kamat A, Koch WH, Nikoloff M, Wu L, Andrews D. The impact of pharmacogenomics on postoperative nausea and vomiting: do CYP2D6 allele copy number and polymorphisms affect the success or failure of ondansetron prophylaxis? Anesthesiology. 2005 Mar;102(3):543-9. doi: 10.1097/00000542-200503000-00011.

  PMID: 15731591 BACKGROUND

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• Pelissier T, Alloui A, Caussade F, Dubray C, Cloarec A, Lavarenne J, Eschalier A. Paracetamol exerts a spinal antinociceptive effect involving an indirect interaction with 5-hydroxytryptamine3 receptors: in vivo and in vitro evidence. J Pharmacol Exp Ther. 1996 Jul;278(1):8-14.

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• Alloui A, Chassaing C, Schmidt J, Ardid D, Dubray C, Cloarec A, Eschalier A. Paracetamol exerts a spinal, tropisetron-reversible, antinociceptive effect in an inflammatory pain model in rats. Eur J Pharmacol. 2002 May 17;443(1-3):71-7. doi: 10.1016/s0014-2999(02)01578-9.

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• Fujii Y, Nakayama M. Efficacy of dexamethasone for reducing postoperative nausea and vomiting and analgesic requirements after thyroidectomy. Otolaryngol Head Neck Surg. 2007 Feb;136(2):274-7. doi: 10.1016/j.otohns.2006.09.013.

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  PMID: 14570668 BACKGROUND

• Andrieu G, Amrouni H, Robin E, Carnaille B, Wattier JM, Pattou F, Vallet B, Lebuffe G. Analgesic efficacy of bilateral superficial cervical plexus block administered before thyroid surgery under general anaesthesia. Br J Anaesth. 2007 Oct;99(4):561-6. doi: 10.1093/bja/aem230. Epub 2007 Aug 6.

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MeSH Terms

Interventions

Ondansetron; Droperidol; Dexamethasone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gilles Lebuffe, MD,PhD

  University hospital of Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)