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

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Dexamethasone 0.4 mg/kg; Drug: Dexamethasone 0.2 mg/kg; Drug: Ketoprofen 1 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02400047

141557A-32 (Other Identifier)

35RC14_9853_DEXA OP

2014-005026-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 580 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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580 participants in 3 patient groups

Dexamethasone 0.2 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone 0.2 mg/kg

Dexamethasone 0.4 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone 0.4 mg/kg

Ketoprofen 1 mg/kg

Active Comparator group

Description:

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.

Treatment:

Drug: Ketoprofen 1 mg/kg