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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control of Stress
Sponsored by
Universidade Cruzeiro do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring Cerebral Palsy, Dental Care, Conscious Sedation, Autonomic Nervous System, Nitrous Oxide

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Cruzeiro do Sul

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cerebral Palsy Subjects

Arm Description

Use of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy

Outcomes

Primary Outcome Measures

Heart Rate
Respiratory Rate
Venham's Score
Nitrous oxide and Oxygen Proportion

Secondary Outcome Measures

Full Information

First Posted
December 13, 2014
Last Updated
December 22, 2014
Sponsor
Universidade Cruzeiro do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02322983
Brief Title
Conscious Sedation With Nitrous Oxide in Control of Stress During Dental Care for Individuals With Cerebral Palsy
Official Title
Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cruzeiro do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Dental Care, Conscious Sedation, Autonomic Nervous System, Nitrous Oxide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebral Palsy Subjects
Arm Type
Experimental
Arm Description
Use of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy
Intervention Type
Behavioral
Intervention Name(s)
Control of Stress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate
Time Frame
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Title
Respiratory Rate
Time Frame
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Title
Venham's Score
Time Frame
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Title
Nitrous oxide and Oxygen Proportion
Time Frame
data were collected and participants were followed up during dental care. An expected average of 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando M Baeder, PhD
Organizational Affiliation
Universidade Cruzeiro do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Cruzeiro do Sul
City
São Paulo
ZIP/Postal Code
01506-000
Country
Brazil

12. IPD Sharing Statement

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

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