Drug Interactions Between Paracetamol and Setrons in Pain Management

Pain Clinical Trial

— PARATRON  

Official title:

Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432977
• Other study ID #: I10 005
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2011
• Last updated: October 30, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• paracetamol /droperidol

• paracetamol / ondansetron

Locations

Country	Name	City	State
France	Chirurgie Ped	Limoges
France	Service Anesthésie	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-pain scores	pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively	4 hours after drug administration	No
Secondary	analgesic consumption	analgesic consumption during 24 hours podt inclusion	24 hours after inclusion	No
Secondary	incidence of nausea and vomiting.	- incidence of nausea and vomiting.	data continuiousley collected during 24 hours	Yes