INTRANASAL KETAMINE IN THE REDUCTION OF THE ISOLATED FRACTURES OF THE HIGHER MEMBER OF THE CHILD TO PEDIATRIC EMERGENCIES

Phase 1

Conditions: a fracture isolated from the distal end of the closed upper limb, requiring a reduction
MedDRA version: 20.0Level: PTClassification code 10016997Term: Forearm fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2017-003643-38-FR

Lead Sponsor: Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 60

Inclusion Criteria

-Male or Female Children
-Aged 4 to 17 years old
- Presenting a fracture isolated from the distal end of the upper limb with closed focus, requiring a reduction
- Fracture dating from <72h
- stable hemodynamics
- Affiliation to a social security scheme
- Signature of the authorization documents of the 2 parents or the representative of the parental authority for the participation of the child in the study
- Signature of informed consent for children over 15 years of age
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Known hypersensitivity to ketamine
-History of epilepsy or known psychiatric illness
-Any child with a developing respiratory disease (asthma, laryngitis, tracheitis)
-Any child who has received an analgesic of level 2 or 3 in the 3 hours preceding the treatment in pediatric emergencies
-High Blood Pressure
-Severe Heart Failure
-polytrauma
-Open fracture
-Proven pregnancy
- Any child requiring pure oxygen ventilation.
- Nitrous oxide should not be used in situations at risk of accumulation in cavities and when its expansion could be dangerous, such as cranial trauma with alteration of the state of consciousness, maxillofacial trauma, pneumothorax, gas embolism , bullous emphysema, sinus or middle ear surgery, internal ear surgery, severe abdominal distension (eg, bowel occlusion)
- A child who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in ocular surgery as long as a gas bubble persists inside the eye and at a minimum for a period of 3 months. Severe post-operative complications may occur in relation to increased intraocular pressure