Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Intranasal Ketamine for Pediatric Fracture Reduction
NCT03525821Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2018
- Primary completion
- Sep 2020
- Countries
- 1
- Sponsor
- Fondation Lenval
- Modality
- Small Molecules
- Drugs
- ketamine
- Conditions
- closed fracture
01
Overview
Phase 3, open-label, single-arm trial of ketamine in closed fracture, sponsored by Fondation Lenval. Primary endpoint: Pain control during and after fracture reduction at 30 months. Started Jul 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
intranasal administration of ketamine
Intranasal ketamine 1 mg/kg combined with nitrous oxide inhalation
03
Who it enrols
Children 4-17 years old with a closed fracture isolated from the distal extremity of the upper limb requiring reduction. Excludes those with respiratory disease, recent analgesic use, or contraindications to nitrous oxide.
04
Endpoints
Primary
Pain control during and after fracture reduction
Secondary
Degree of sedation
Evaluation of tolerance
Evaluation of child's feeling of pain
Nurse's assessment of preparation feasibility
Nurse's assessment of administration feasibility
Beyond the preview
Go deeper on NCT03525821.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03525821.