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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02400047 |
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Date of registration:
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23/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
DEXA OP |
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Scientific title:
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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 |
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Date of first enrolment:
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June 3, 2015 |
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Target sample size:
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580 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02400047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Nausea and Vomiting
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Intervention(s)
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Drug: Dexamethasone 0.2 mg/kg
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Drug: Ketoprofen 1 mg/kg
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Drug: Dexamethasone 0.4 mg/kg
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Primary Outcome(s)
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Maximum intensity of postoperative pain
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Length of stay
[Time Frame: 24 hours]
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Parent's satisfaction
[Time Frame: 24 hours]
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Rescue analgesic consumption
[Time Frame: 24 hours]
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Side effects
[Time Frame: 24 hours]
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Intensity of postoperative pain
[Time Frame: 24 hours]
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Pediatric Anesthesia Emergence Delirium Scale (PAEDS)
[Time Frame: 24 hours]
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Secondary ID(s)
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35RC14_9853_DEXA OP
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141557A-32
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2014-005026-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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