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Drug Interactions Between Paracetamol and Setrons in Pain Management (PARATRON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432977
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
The aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after

Condition or disease Intervention/treatment Phase
Pain Drug: paracetamol /droperidol Drug: paracetamol / ondansetron Phase 3

Detailed Description:

Tonsillectomy is a common operation performed in children that is associated with marked pain and a high incidence of nausea and vomiting. Therefore, national and international guidelines have recommended the use of a setron as a prevention to nausea and vomiting and also the systematic administration of paracetamol to help in the control of postoperative pain. However, a potential interaction between setrons and paracetamol has been reported in different animal studies and in human volunteers although its existence has never been found in the clinic. Indeed, several hypotheses are proposed to explain the mechanism of action of paracetamol in the treatment of pain. However, a recent one involves the endocannabinoid system and spinal serotonin receptors. Serotonin receptors are also involved in the mechanism of action of antiemetics such as setrons. Indeed, these drugs are serotonin antagonists. Therefore, the investigators hypothesized that the concomitant administration of paracetamol and ondansetron leads to an interaction that will decrease the analgesic effect of paracetamol.

Patients aged 2-7 years old and scheduled for a tonsillectomy will be recruited. They will all receive intraoperatively intravenous paracetamol together with either ondansetron or droperidol. Pain scores using the CHEOPS scale will be recorded for 24 hours. Furthermore, patients will receive i.v. morphine during the operation and in the recovery room if necessary and a non-steroidal anti-inflammatory drug for postoperative pain; on the ward, oral codeine will be administered when needed. Pain scores will be recorded regularly for up to 24 hours together with opioid consumption and the incidence of nausea and vomiting in the same period. Any adverse event will also be recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: comparateur
paracetamol / droperidol
Drug: paracetamol /droperidol
Experimental: Eperimental
paracetamol / ondansetron
Drug: paracetamol / ondansetron

Primary Outcome Measures :
  1. -pain scores [ Time Frame: 4 hours after drug administration ]
    pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively

Secondary Outcome Measures :
  1. analgesic consumption [ Time Frame: 24 hours after inclusion ]
    analgesic consumption during 24 hours podt inclusion

  2. incidence of nausea and vomiting. [ Time Frame: data continuiousley collected during 24 hours ]
    - incidence of nausea and vomiting.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • tonsillectomy in a child 2-7 years old who is hospitalized for at least 24 hours ;
  • informed consent from one parent at least

Exclusion Criteria:

  • hospital stay of less than 24 hours ;
  • patient already on pain medication ;
  • allergic patient with a contra-indication to one of the study drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432977

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Chirurgie Ped
Limoges, France, 87042
Service Anesthésie
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges

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Responsible Party: University Hospital, Limoges Identifier: NCT01432977     History of Changes
Other Study ID Numbers: I10 005
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Autonomic Agents
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Adjuvants, Anesthesia
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents