Conscious Sedation With Nitrous Oxide in Control of Stress During Dental Care for Individuals With Cerebral Palsy

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322983
• Other study ID #: 3307801700P7
• Secondary ID: CE/UCS - 044/201
• Status: Completed
• Phase: N/A
• First received: December 13, 2014
• Last updated: December 22, 2014
• Start date: February 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Universidade Cruzeiro do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Control of Stress
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.

Locations

Country	Name	City	State
Brazil	Universidade Cruzeiro do Sul	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cruzeiro do Sul	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate		data were collected and participants were followed up during dental care. An expected average of 1 hour.	Yes
Primary	Respiratory Rate		data were collected and participants were followed up during dental care. An expected average of 1 hour.	Yes
Primary	Venham's Score		data were collected and participants were followed up during dental care. An expected average of 1 hour.	No
Primary	Nitrous oxide and Oxygen Proportion		data were collected and participants were followed up during dental care. An expected average of 1 hour.	Yes