Intranasal Dexmedetomidine for Sedated Hearing Testing

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    60
  • sponsor
    Fondation Lenval
Updated on 24 January 2021

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 2 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.

Description

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. An intranasal administration avoids the pain and discomfort of a venous access insertion.

Dexmedetomidine is a sedative drug with an action on the 2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The treatment will be administrated by intranasal way at a dosage of 2,5g/ kg in a single administration under continuous cardiorespiratory monitoring for 2 hours..

The objective of this work is to evaluate the effectiveness of intranasal dexmedetomidine in the realization of the auditory brainstem response at the child with a cognitive or behavioral disorder

This study will consist of research involving non-randomized, monocentric prospective interventional for a duration of 30 months. Patients from 1 year of age and under 16 years, in context of suspicion of deafness will be included. In view of active queue of otorhinolaryngology service of Nice University Hospital and taking into account lost sight, the investigators can include 60 patients, to have a representative sample of concerned pediatric population.

The primary endpoint will be 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.

Despite the lack of specific protocols, the applications of dexmedetomidine in children for many diagnostic procedures have been studied in the past few years.

Any prospective study about the efficacy of dexmedetomidine for auditory brainstem response testing has been yet conducted in children

Details
Condition BAER
Treatment Dexmedetomidine Hydrochloride
Clinical Study IdentifierNCT03530371
SponsorFondation Lenval
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 15 yrs?
Gender: Male or Female
Do you have BAER?
Do you have any of these conditions: Do you have BAER??
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
Clear my responses

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