Cerebral Palsy Clinical Trial
Official title:
Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.
Cerebral Palsy induces oral alterations that impact on oral health, requiring dental treatment. The objective of this study was to evaluate the use of conscious sedation with nitrous oxide (N2O) in the control of stress during dental treatment in individuals with Cerebral Palsy.
Were invited and accepted to participate in this study, 77 individuals with Cerebral Palsy
who attended the outpatient clinic of San Francisco Home School (SFHS) at the time of data
collection.
This study served as a non-randomized experimental trial conducted between 2011/2012 at
dental ambulatory in the SFHS. Dental care routines have been established, by standardizing
procedures and ensuring the reproducibility of the method of sedation. In the initial
consultation, medical history taking (collecting sociodemographic data of the participants)
and dental examination was performed. Data relating to the Cerebral Palsy clinical standard
were collected from medical records of patients and noted in the evaluation sheet developed
specifically for this research. Were provided to guardians the clarifications regarding
sedation technique and treatment planning.
At dental examination the diagnostic criteria of caries followed those proposed by the World
Health Organization (WHO). On the second visit, the patient was stabilized in the dental
chair under mechanical contention. Performed adaptation and selection of nasal mask,
monitoring equipment were positioned, starting the observation and recording of the
behavioral and physiological records in the evaluation sheets. The proportion of gas was
manipulated relative to the percentage between nitrous oxide and oxygen to achieve optimal
sedation. In this study, it was considered a good sedation for Cerebral Palsy patient when
he showed a certain degree of relaxation, which becomes more cooperative with treatment.
Behavioral assessment in relation to dental treatment was measured by Venham's Score,
standard used for behavioral assessment of the dental patient, and the measurement performed
according to the patient's behavior during the dental procedure.
Due to the subjectivity which compose the diagnosis of diseases or behavior analysis, it is
common to occur some variation in the results. In the specific situation of a study, there
is the aggravation of multiple observations be conducted on the same day, so that fatigue
could lead to inconsistent diagnoses. For this reason, only one patient per day received
dental care with nitrous oxide (N2O). In light of the above considerations, two dentists
were calibrated to evaluate behavior in Venham's Score.
Behavioral and the physiological parameters evaluations of patients referred for dental
treatment were performed in four stages: pre-sedation, induction, sedated patient and in the
end.
Measures of Heart Rate and Respiratory Rate were recorded in all time intervals. The Heart
Rate was later corrected for physiological cardiac variability in the different age groups
of patients.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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