Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss. MedDRA version: 20.1 Level: PT Classification code 10049507 Term: Brain stem auditory evoked response System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Dexdor
Product Name: DEXDOR
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Child aged 1 to 15 years old -ASA 1 or 2 (American Society Anesthesiologists scale patient) -Need to evaluate the child audition in a context of suspicion of deafness, delay of language, global delay of the development, the risk factors of hearing loss -Impossibility to realize a hearing test by conventional audiogram or behavioral due to a cognitive or behavioral disorder of the child -Affiliation to 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 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
Exclusion criteria: - Heart disease or heart rhythm disorder - Pneumopathy or asthmatic crisis in previous 2 weeks in the examination - Recent used of digoxine or beta-blocker - Use of anti-epileptic or psychotropic drugs - Medical history of sleep apnea - Receptor alpha2 agonist allergy - Gastrooesophageal reflux disease - Upper airway abnormality - Acute cerebrovascular diseases - Neurologic disorders ( cranial trauma and after neurosurgical operation) - Recent CVA - Moyamoya disease - General anesthesia planned for another procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the effectiveness of intranasal dexmedetomidine in the realization of the auditory brainstem response at the child with a cognitive or behavioral disorder.;Secondary Objective: 1) Tolerance study of dexmedetomidine for sedated auditory branstem response testing at the child 2) Evaluation of time to obtain of a correct sedation. 3) Evaluation of time to get a conscient wake up.;Primary end point(s): the rate of children included in the study who could determine the auditory threshold. The non-determination of this threshold (or the determination by resorting to general anesthesia or sedation of another type) regardless of the cause will be considered a failure.;Timepoint(s) of evaluation of this end point: at the end of the realization of auditory brainstem response | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The tolerance will be studied by the collection of the following undesirable effects: - hypotension, bradycardia: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject under waking conditions - hypertension: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject in waking conditions - decrease in oxygenation: decrease in oxygen saturation <90% These effects will be assessed by cardiorespiratory monitoring during the examination. A routine home phone call on D1 will collect information about possible unexpected side effects. 2) The speed of obtaining a correct sedation is studied by the delay of falling asleep: time in minutes between the administration of the drug and the obtaining of a correct sedation (4, 5 or 6 of the score of Ramsey). 3) The speed of recovery of vigilance is studied by the wake up time: time between the end of the examination, (defined by the end of the recording and the disconnection of the electrodes) and the recovery of the vigilance of the child , evaluated by the Aldrete score (Appendix 2). A score of 9 or more determines a correct recovery of alertness and the possibility of returning home. The child will be reevaluated every 10 minutes until this score is reached.;Timepoint(s) of evaluation of this end point: 1) during examination and by phone one day after 2) from introduction of the sedation to feel asleep 3) from the end of examination to wake-up of patient | — |
Countries
France
Contacts
Public Contactclinical trials information
CHU de Nice
Outcome results
None listed