EUCTR2018-001466-42-FR
Active, not recruiting
Phase 1
EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATEDAUDITORY BRAINSTEM RESPONSE TESTING - DEXMEDETOMIDINE - ABR
Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVA0 sites60 target enrollmentApril 19, 2018
ConditionsChild requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.MedDRA version: 20.1Level: PTClassification code 10049507Term: Brain stem auditory evoked responseSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
DrugsDexdor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.
- Sponsor
- Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVA
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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