Intranasal Dexmedetomidine for Sedated Hearing Testing

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.

This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.

Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.

The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization.

Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Lenval
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Child aged 1 to 15 years old

• American Society Anesthesiologists (ASA) scale patient 1 or 2

• 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

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 cerebral vascular accident

• Moyamoya disease

• General anesthesia planned for another procedure