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

PHASE3CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

June 3, 2015

Primary Completion Date

July 18, 2019

Study Completion Date

July 18, 2019

Conditions
Postoperative Nausea and Vomiting
Interventions
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.

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.

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.

Trial Locations (1)

35000

Rennes University Hospital, Rennes

All Listed Sponsors
lead

Rennes University Hospital

OTHER

NCT02400047 - Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP | Biotech Hunter | Biotech Hunter