Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02400047
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Dexamethasone 0.2 mg/kg Drug: Dexamethasone 0.4 mg/kg Drug: Ketoprofen 1 mg/kg Phase 3

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400047


Contacts
Layout table for location contacts
Contact: Nicolas Nardi, MD nicolas.nardi@chu-rennes.fr
Contact: Eric Wodey, MD erci.wodey@chu-rennes.fr

Locations
Layout table for location information
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35000
Contact: Nicolas Nardi, MD       nicolas.nardi@chu-rennes.fr   
Principal Investigator: Nicolas Nardi, MD         
Sub-Investigator: Eric Wodey, MD         
Sponsors and Collaborators
Rennes University Hospital

Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02400047     History of Changes
Other Study ID Numbers: 35RC14_9853_DEXA OP
2014-005026-35 ( EudraCT Number )
141557A-32 ( Other Identifier: ANSM )
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by Rennes University Hospital:
Paediatric surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pharmaceutical Solutions
Anesthetics
Dexamethasone
Dexamethasone acetate
Ketoprofen
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic