a fracture isolated from the distal end of the closed upper limb, requiring a reduction MedDRA version: 20.0 Level: PT Classification code 10016997 Term: Forearm fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: KETAMINE
Pharmaceutical Form: Injection
INN or Proposed INN: KETAMINE
Other descriptive name: KETAMINE HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: e
Sponsors
Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of ketamine intranasal efficacy in combination with nitrous oxide in the reduction of closed fractures isolated from the upper limb in children in pediatric emergencies, DURING and AFTER the procedure.;Secondary Objective: 1. Evaluation of the degree of sedation during the gesture 2. Assessment of treatment tolerance in children during and after the procedure 3. Evaluation of the child's feeling of pain after the reduction 4. Evaluation of the feasibility of nurse preparation and administration.;Primary end point(s): The effectiveness of ketamine will be assessed by measuring pain control during and after fracture reduction. Measurement of pain intensity will be carried out using the EVENDOL 5-item hetero-evaluation of pain, validated in children. Effective pain control will be defined by a score obtained with the EVENDOL <6/15 scale during reduction and after reduction. Our criterion will therefore be binary, control or not pain.;Timepoint(s) of evaluation of this end point: During and after the fracture reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. 5 minutes after the administration of the ketamine 2. for the duration of the procedure, from the introduction of sedation to the end of the post-reduction period 3. after the reduction 4. after the administration of the treatment;Secondary end point(s): 1. The evaluation of the degree of sedation will be made 5 minutes after the administration of the ketamine by the internationally validated anesthetic score "University of Michigan Sedation Scale" based on 5 items ranging from the state of awakening to no response to stimulation. The level of sedation sought is a score equal to 1 corresponding to a relaxed / sleeping patient and having an appropriate response to the weak stimulation. If the level of sedation is the one sought, the gesture of manual reduction of the fracture focus by aligning the bone fragments will be performed. 2. Treatment tolerance in children will be assessed through the collection of adverse reactions for the duration of the procedure, from the introduction of sedation to the end of the post-reduction period . Possible side effects are described in section 10 "Undesirable Events". For each adverse event, the patient rate with at least one occurrence of the effect should be determined. 3. The assessment of the child's feeling of pain after the reduction will be carried out by a closed question: "Have you had any pain?" Possible answers: No, Yes a little, Yes a lot. 4. The nurse's assessment of the feasibility of the preparation and administration of the medicinal product will be based on a questionnaire based on two closed questions on the timeliness of drug preparation and the ease of administration of the drug intranasally: "Are you satisfied with the speed of preparation of intranasal ketamine? " Answers: Not satisfied, Partially satisfied, Satisfied, Very satisfied "Are you satisfied with the ease of administration of intranasal ketamine? " Answers: Not satisfied, Partially satisfied | — |
Countries
France
Contacts
Public ContactClinical trials information
CHU de Nice
Outcome results
None listed