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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

NCT02400047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2019-11-06

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2019-07-18
Completion
2019-07-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400047 on ClinicalTrials.gov