NCT03530371

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

May 4, 2018

Last Update Submit

March 16, 2023

Conditions

Auditory Brainstem Response

Outcome Measures

Primary Outcomes (1)

  • quality of diagnostic

    measure the rate of children for who the auditory threshold is obtained with drug sedation condition.

    5 minutes after the realization of auditory test

Secondary Outcomes (3)

  • tolerance of treatment

    from drug administration to 24 hours after administration of drug

  • time of correct sedation

    from 5 minutes after drug administration to 5 minutes before auditory test

  • time of vigilance recovery

    from 5 minutes after auditory test to 5 minutes after the patient wake up (Aldrete score equal to 9)

Study Arms (1)

Dexmedetomidine Hydrochloride

EXPERIMENTAL

sedation of patients to perform auditory test

Drug: Dexmedetomidine Hydrochloride

Interventions

Dexmedetomidine HydrochlorideDRUG

intranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients

Also known as: sedated auditory brainstem response
Dexmedetomidine Hydrochloride

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux pédiatriques de Nice CHU-Lenval

Nice, 06200, France

Location

Related Publications (1)

  • Giordano A, Lehner B, Voicu A, Donzeau D, Joulie A, Froissant L, Fontas E, Bailleux S. Intranasal dexmedetomidine for sedation in ABR testing in children: No pain, big gain! Int J Pediatr Otorhinolaryngol. 2024 Jun;181:111981. doi: 10.1016/j.ijporl.2024.111981. Epub 2024 May 11.

    PMID: 38749259DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ana GIORDANO, MD

    Hôpitaux Pédiatriques de Nice CHU-LENVAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 21, 2018

Study Start

May 2, 2019

Primary Completion

November 16, 2021

Study Completion

December 31, 2021

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

FR(1)