Drug Interactions Between Paracetamol and Setrons in Pain Management (PARATRON)
|Pain||Drug: paracetamol /droperidol Drug: paracetamol / ondansetron||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children|
- -pain scores [ Time Frame: 4 hours after drug administration ]pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively
- analgesic consumption [ Time Frame: 24 hours after inclusion ]analgesic consumption during 24 hours podt inclusion
- incidence of nausea and vomiting. [ Time Frame: data continuiousley collected during 24 hours ]- incidence of nausea and vomiting.
|Study Start Date:||September 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: comparateur
paracetamol / droperidol
|Drug: paracetamol /droperidol|
paracetamol / ondansetron
|Drug: paracetamol / ondansetron|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432977
|Limoges, France, 87042|
|Limoges, France, 87042|