Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability

Rationale: Many patients with intellectual disability lack adequate cognitive strategies to cope with the stress and fear accompanying medical or dental treatment. This makes surgical or dental procedures for these patients stressful if not impossible to tolerate without general anesthesia. Although general anesthesia provides the certainty of good access to the patient, the workup, induction and emergence of general anesthesia is often even more stressful for this vulnerable group of patients. A safe and reliable sedative with a quick and easy route of administration can provide patient comfort and ensure good cooperation and access.
Intranasal administration of dexmedetomidine has been proven to be quick, comfortable and reliable in providing dose dependent sedation levels ranging from premedicative anxiolysis to deep conscious sedation. The literature only bases these conclusions on studies in adults with full cognitive function or children. Theoretically dexmedetomidine may provide an excellent alternative to more commonly used sedatives like benzodiazepines. Dexmedetomidine’s sympathicolytic effect can alleviate fear not by suppressing the cerebral projection of fear but by reducing the intrinsic activity of the brainstem arousal system and of the autonomous nervous system. Especially for patients without the cognitive coping abilities this may provide good and safe sedation. The study will focus on the feasibility and efficacy of dexmedetomidine for conscious sedation after nasal administration in these patients.


Objective: To demonstrate non-inferiority of conscious

sedation with intranasal dexmedetomidine for performing

dental care in patients with intellectual disability and

dentophobia.


Study design: A single centre therapeutic randomized

non-inferiority study.



Study population: 30 ASA 1-3 patients with intellectual disability (mild to profound) who require dental examination or treatment, but in whom dental examination or treatment was not possible without pharmacological support in the dental policlinic ‘Bijzondere Tandheelkunde’ because of severe dentophobia.

Intervention: Intranasal administration of 1,5 mcg/kg dexmedetomidine (using a medical atomizer device).



Main study parameters/endpoints:

• Proportion of patients in whom dental treatment

under procedural sedation with intranasal dexmedetomidine

can be finished and is not terminated because of inadequate

sedation.

• Proportion of patients in whom dental treatment

under general anesthesia can be finished and is not

terminated because of inadequate sedation.

• mRASS-score at specified dental treatment events

after dexmedetomidine treatment compared to agitation

score descriptor from the non-pharmacological Trial-of-

Treatment

• mRASS-score at specified events during induction for

general anesthesia compared to agitation score descriptor

from the non-pharmacological Trial-of- Treatment

This is a therapeutic trial. Participation in the study can

provide several benefits to the patients.

Induction of general anesthesia is a frightening event for

PwID whose ability to deal with fear on a cognitive basis is

reduced. Being hooked up to the monitoring system, the

need to breath in a ventilator mask with the strange smell of

volatile anesthetics or the placing of an intravenous canula

are all fearfull moments. This often leads to necessary but

very unwanted cases of frightened, fighting patients. Not

seldom do these patients have to be restrained for their own

good.

It is the inability to cope with stress and fear on a cognitive

basis that forms the group relatedness for this specific trial.

Dealing with frightened PwIDs is completely different from

dealing with frightened patients with full cognitive

capabilities. There is no conceiveable substitute for the

unique clinical problem faced by the specialized dentist and

the anesthetist.

Patients will receive either the standard care (dental

treatment under general anesthesia) or they will reiceve

anxiolytic procedural sedation. In either case the planned,

necessary dental treatment will be completed. Patients who

can not be treated with dexmedetomidine procedural

sedation alone will receive a general anesthetic in the same

procedure to complete their dental treatment. Even if the full

dental treatment cannot be completed after

dexmedetomidine administration, the sedative effects of IN

dexmedetomidine will make tolerance of usually unpleasant

procedures easier and less frightening. Studies in children

and adults without intellectual disabilities have shown that

dexmedetomidine is well tolerated when administered

intranasally by either droplets or atomizer spray. In children

and adults without intellectual disabilities, the dose used has

been shown to be safe and effective.

The presence of a dedicated anaesthesiologist will be

constant during the study period in which dexmedetomidine

is used. The sedation with dexmedetomidine has no

implications for general anesthesia (should this be indicated)

that can not easily be accommodated for by the attending

anesthetic team.

Tolerance of the treatment is measured constantly by

sedation and agitation scores. When a patient has a

sedation/agitation score indicating less tolerance to

treatment under sedation compared to treatment in the OPD,

this signals that the treatment is no longer in the patients

best interest and they will receive standard institution

treatment (i.e. be converted to GA) and study procedures

will stop.

The dentist in attendance is a specialist in providing dental

care to specifically this vulnerable group of patients, and is

trained in using both non-pharmacolgical and

pharmacological strategies in the treatment of PwIDs and

dentophobia.

No follow up visits will be required.

After the dental procedure the subject will be in normal post-surgical care. The study medication is not expected to have implications for this period. As is normal after procedural sedation and daycare surgery under general anesthesia, subjects will be discharged with adult supervision and will be asked to spend the night following the procedure under the care of a responsible adult. Subjects not planned for daycare surgery will be admitted to the ward as is normal. No follow up visits will be required.

Dexmedetomidine when used intranasally fopr procedural sedation does not significantly decrease the proportion of patients with intellectual disability and dentophobia needing general anesthesia for dental treatemnt

Start of dental treatment until completion of dental treatment or until induction of general anesthesia

Single dose intranasal administration of dexmedetomidine