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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexamethasone 0.2 mg/kg
* Drug: Dexamethasone 0.4 mg/kg
* Drug: Ketoprofen 1 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone 0.2 mg/kg<br>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. | Drug: Dexamethasone 0.2 mg/kg<br>* 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.<br>|
| Experimental: Dexamethasone 0.4 mg/kg<br>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. | Drug: Dexamethasone 0.4 mg/kg<br>* 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.<br>|
| Active Comparator: Ketoprofen 1 mg/kg<br>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. | Drug: Ketoprofen 1 mg/kg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum intensity of postoperative pain | Maximum intensity of postoperative pain assessed in PACU using the Faces Legs Activity Cry Consolability tool (FLACC, 0-10) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium Scale (PAEDS) | Pediatric Anesthesia Emergence Delirium Scale (PAEDS) | 24 hours | 
| Intensity of postoperative pain | Intensity of postoperative pain assessed in ambulatory unit and at home one day after surgery. (FLACC, 0-10). | 24 hours | 
| Rescue analgesic consumption | Rescue analgesic consumption in the PACU, ambulatory unit and at home. | 24 hours | 
| Side effects | Side effects during hospitalization (PONV, postoperative bleeding) and in the first 24 hours post-surgery (PONV, fever, bleeding, behavior modification and sleep disorders). | 24 hours | 
| Length of stay | Length of stay in ambulatory unit (time of possible discharge using Pediatric Post Anesthetic Discharge Scoring System and the actual time of discharge). | 24 hours | 
| Parent's satisfaction | Parent's satisfaction on a four-point Likert scale | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paediatric surgery