Drug Interactions Between Paracetamol and Setrons in Pain Management

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01432977
• Date of registration: 09/09/2011
• Prospective Registration: No
• Primary sponsor: University Hospital, Limoges
• Public title: Drug Interactions Between Paracetamol and Setrons in Pain Management PARATRON
• Scientific title: Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children
• Date of first enrolment: September 2011
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01432977
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 7 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: paracetamol /droperidol

Drug: paracetamol / ondansetron

Primary Outcome(s)

-pain scores [Time Frame: 4 hours after drug administration]

Secondary Outcome(s)

analgesic consumption [Time Frame: 24 hours after inclusion]

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

Secondary ID(s)

I10 005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors