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

NCT02322983 | Completed DMC

• 2 other identifiers: 3307801700P7CE/UCS - 044/2010
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Dental Care; Conscious Sedation; Autonomic Nervous System; Nitrous Oxide

Outcome Measures

Primary Outcomes (4)

• Heart Rate

  data were collected and participants were followed up during dental care. An expected average of 1 hour.

• Respiratory Rate

  data were collected and participants were followed up during dental care. An expected average of 1 hour.

• Venham's Score

  data were collected and participants were followed up during dental care. An expected average of 1 hour.

• Nitrous oxide and Oxygen Proportion

  data were collected and participants were followed up during dental care. An expected average of 1 hour.

Study Arms (1)

Cerebral Palsy Subjects

EXPERIMENTAL

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

Behavioral: Control of Stress

Interventions

Control of Stress BEHAVIORAL

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.

Cerebral Palsy Subjects

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cruzeiro do Sul: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Universidade Cruzeiro do Sul

São Paulo, São Paulo, 01506-000, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fernando M Baeder, PhD

  Universidade Cruzeiro do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and professor of the degree program.

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 23, 2014
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

BR (1)