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

December 22, 2014 updated by: Fernando Martins Baeder, Universidade Cruzeiro do Sul

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01506-000
        • Universidade Cruzeiro do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cerebral Palsy Subjects
Use of conscious sedation with nitrous oxide in the control of stress during dental treatment in individuals with Cerebral Palsy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Respiratory Rate
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Venham's Score
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
data were collected and participants were followed up during dental care. An expected average of 1 hour.
Nitrous oxide and Oxygen Proportion
Time Frame: data were collected and participants were followed up during dental care. An expected average of 1 hour.
data were collected and participants were followed up during dental care. An expected average of 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Cruzeiro do Sul

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernando M Baeder, PhD, Universidade Cruzeiro do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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