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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01432977
First received: September 9, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Pain
Drug: paracetamol /droperidol
Drug: paracetamol / ondansetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • -pain scores [ Time Frame: 4 hours after drug administration ] [ Designated as safety issue: No ]
    pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively


Secondary Outcome Measures:
  • analgesic consumption [ Time Frame: 24 hours after inclusion ] [ Designated as safety issue: No ]
    analgesic consumption during 24 hours podt inclusion

  • incidence of nausea and vomiting. [ Time Frame: data continuiousley collected during 24 hours ] [ Designated as safety issue: Yes ]
    - incidence of nausea and vomiting.


Enrollment: 72
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: comparateur
paracetamol / droperidol
Drug: paracetamol /droperidol
Experimental: Eperimental
paracetamol / ondansetron
Drug: paracetamol / ondansetron

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.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432977

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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01432977     History of Changes
Other Study ID Numbers: I10 005
Study First Received: September 9, 2011
Last Updated: October 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Acetaminophen
Droperidol
Ondansetron
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 26, 2014