Skip to main content
OpenTrials
Completed

NCT Number: NCT02400047

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 0.2 mg/kg

Drug

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.

Dexamethasone 0.4 mg/kg

Drug

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.

Ketoprofen 1 mg/kg

Drug

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.

Primary outcomes

  1. Maximum intensity of postoperative pain

    Time frame: 1 hour

    Maximum intensity of postoperative pain assessed in PACU using the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)

Secondary outcomes

  1. Pediatric Anesthesia Emergence Delirium Scale (PAEDS)

    Time frame: 24 hours

    Pediatric Anesthesia Emergence Delirium Scale (PAEDS)

  2. Intensity of postoperative pain

    Time frame: 24 hours

    Intensity of postoperative pain assessed in ambulatory unit and at home one day after surgery. (FLACC, 0-10).

  3. Rescue analgesic consumption

    Time frame: 24 hours

    Rescue analgesic consumption in the PACU, ambulatory unit and at home.

  4. Side effects

    Time frame: 24 hours

    Side effects during hospitalization (PONV, postoperative bleeding) and in the first 24 hours post-surgery (PONV, fever, bleeding, behavior modification and sleep disorders).

  5. Length of stay

    Time frame: 24 hours

    Length of stay in ambulatory unit (time of possible discharge using Pediatric Post Anesthetic Discharge Scoring System and the actual time of discharge).

  6. Parent's satisfaction

    Time frame: 24 hours

    Parent's satisfaction on a four-point Likert scale

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: DEXA OP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2015
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.