Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP

• Status: Completed
• Trial end date: 2019-07-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Anesthetics; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ketoprofen; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Children, aged 1 to 16 years

• Undergoing surgery (orchiopexy, inguinal hernia, circumcision, adenoidectomy, tonsillectomy or orthopedic act with osteosynthesis)

• Parental consent

Exclusion Criteria:

• Contraindication to NSAI or DXM

• Hypersensitivity to ketoprofen, DXM, hypnovel or atarax

• Porphyria

• Long QT Syndrome

• Renal or hepatic impairment

• Corticosteroid consumption the week before surgery

• NSAI consumption within 48 hours before surgery

• IV induction for full stomach or myopathic patient.

• French language not spoken by parents.

• Simultaneous participation in biomedical research on health products