Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP
Keywords
Abstract
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.
Dates
| Last Verified: | 10/31/2019 |
| First Submitted: | 03/22/2015 |
| Estimated Enrollment Submitted: | 03/24/2015 |
| First Posted: | 03/25/2015 |
| Last Update Submitted: | 11/04/2019 |
| Last Update Posted: | 11/05/2019 |
| Actual Study Start Date: | 06/02/2015 |
| Estimated Primary Completion Date: | 07/17/2019 |
| Estimated Study Completion Date: | 07/17/2019 |
Condition or disease
Intervention/treatment
Drug: Dexamethasone 0.2 mg/kg
Drug: Dexamethasone 0.4 mg/kg
Drug: Ketoprofen 1 mg/kg
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dexamethasone 0.2 mg/kg 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 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. |
| Experimental: Dexamethasone 0.4 mg/kg 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 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. |
| Active Comparator: Ketoprofen 1 mg/kg 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 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. |
Eligibility Criteria
| Ages Eligible for Study | 1 Year To 1 Year |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Maximum intensity of postoperative pain [1 hour]
Secondary Outcome Measures
1. Pediatric Anesthesia Emergence Delirium Scale (PAEDS) [24 hours]
2. Intensity of postoperative pain [24 hours]
3. Rescue analgesic consumption [24 hours]
4. Side effects [24 hours]
5. Length of stay [24 hours]
6. Parent's satisfaction [24 hours]
