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

NCT02400047 | Completed Phase 3

• 3 other identifiers: 35RC14_9853_DEXA OP2014-005026-35141557A-32
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Paediatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pediatric Anesthesia Emergence Delirium Scale (PAEDS)

  24 hours

• Intensity of postoperative pain

  24 hours

• Rescue analgesic consumption

  24 hours

• Side effects

  24 hours

• Length of stay

  24 hours

Study Arms (3)

Dexamethasone 0.2 mg/kg

EXPERIMENTAL

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

Dexamethasone 0.4 mg/kg

EXPERIMENTAL

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

Ketoprofen 1 mg/kg

ACTIVE COMPARATOR

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

Interventions

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 0.2 mg/kg

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.

Dexamethasone 0.4 mg/kg

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.

Ketoprofen 1 mg/kg

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children, aged 1 to 16 years
• Undergoing surgery (orchiopexy, inguinal hernia, circumcision, adenoidectomy, tonsillectomy or orthopedic act with osteosynthesis)
• Parental consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Ketoprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: June 3, 2015
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

FR (1)