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

Postoperative Nausea and Vomiting Clinical Trial

— DEXA OP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400047
• Other study ID #: 35RC14_9853_DEXA OP
• Secondary ID: 2014-005026-3514
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2015
• Est. completion date: July 18, 2019

Study information

• Verified date: November 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum intensity of postoperative pain	Maximum intensity of postoperative pain assessed in PACU using the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)	1 hour
Secondary	Pediatric Anesthesia Emergence Delirium Scale (PAEDS)	Pediatric Anesthesia Emergence Delirium Scale (PAEDS)	24 hours
Secondary	Intensity of postoperative pain	Intensity of postoperative pain assessed in ambulatory unit and at home one day after surgery. (FLACC, 0-10).	24 hours
Secondary	Rescue analgesic consumption	Rescue analgesic consumption in the PACU, ambulatory unit and at home.	24 hours
Secondary	Side effects	Side effects during hospitalization (PONV, postoperative bleeding) and in the first 24 hours post-surgery (PONV, fever, bleeding, behavior modification and sleep disorders).	24 hours
Secondary	Length of stay	Length of stay in ambulatory unit (time of possible discharge using Pediatric Post Anesthetic Discharge Scoring System and the actual time of discharge).	24 hours
Secondary	Parent's satisfaction	Parent's satisfaction on a four-point Likert scale	24 hours