- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322983
Conscious Sedation With Nitrous Oxide in Control of Stress During Dental Care for Individuals With Cerebral Palsy
Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 01506-000
- Universidade Cruzeiro do Sul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cerebral Palsy medical diagnosis;
- Age over 3 years old without distinction by gender;
- Patients with any clinical patterns of Cerebral Palsy;
- Patients with caries in at least two molars (primary or permanent), indicating anesthetic use for performing the restorative procedure.
Exclusion Criteria:
- Patients with chronic respiratory problems (such as chronic bronchitis, COPD) or acute (like flu with nasal congestion and active pneumonia) as these conditions contraindicate the use of N2O;
- Cerebral Palsy patients with genetic syndromes associated;
- Patients whose caregivers refused to sign the Instrument of Consent and the Consent of the Use of Conscious Sedation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cerebral Palsy Subjects
Use of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy
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To control stress were measured (at different times: T1, T2, T3 and T4) Venham's Score, Heart Rate, Respiratory Rate, and the titration of gases.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart Rate
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
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data were collected and participants were followed up during dental care. An expected average of 1 hour.
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Respiratory Rate
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
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data were collected and participants were followed up during dental care. An expected average of 1 hour.
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Venham's Score
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
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data were collected and participants were followed up during dental care. An expected average of 1 hour.
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Nitrous oxide and Oxygen Proportion
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
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data were collected and participants were followed up during dental care. An expected average of 1 hour.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fernando M Baeder, PhD, Universidade Cruzeiro do Sul
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3307801700P7
- CE/UCS - 044/2010 (Registry Identifier: Ethics and Research Committee of Unicsul)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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