Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory
      care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative
      care is recommended for effective postoperative analgesia in children. However, intravenous
      ketoprofen doesn't have the marketing authorization for use in children less than 15 years
      old and its use is mainly justified by the absence of therapeutic alternatives. Recently,
      findings from published studies suggest that dexamethasone (DXM), which is actually
      recommended to prevent PONV for children "at risk", at a dose of 0.1mg/kg, would have
      analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).

      Main objective :

      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of
      postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).

      Secondary objectives :

      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen
      (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the
      consumption of rescue analgesics and the side effects in the first 24 hours after surgery.
    

Detailed description: 
      Methodology :

      Non inferiority, phase III, therapeutic trial. Prospective, randomized double-blinded,
      monocentric study. Inclusion of 567 patients. Inclusion will be performed by the
      anesthesiologist, the day of surgery during the preoperative visit.

      Each patient will be randomised to receive intraoperative DXM (0.2mg/kg), DXM (0.4mg/kg) (max
      20mg) or ketoprofen (1mg/kg) (max 100mg).

      The clinical data will be collected prospectively in an electronic database. If the
      hypothesis of non-inferiority is verified, it is planned to test the superiority of the
      hypothesis secondarily.

      Treatment :

      Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule
      solution) at 0.2 mg / kg or 0.4 mg/kg or single injection of ketoprofen (Medac ketoprofen ®
      100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and
      before surgery incision.
    

Intervention name(s): Dexamethasone 0.2 mg/kg; Dexamethasone 0.4 mg/kg; Ketoprofen 1 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.2 mg / kg after general anesthesia induction and before surgery incision.; Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.4 mg / kg after general anesthesia induction and before surgery incision.; Single injection of ketoprofen (Medac ketoprofen ® 100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and before surgery incision.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ketoprofen; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Paediatric surgery