Isolite and Dental Treatment Under Conscious Sedation
Study Details
Study Description
Brief Summary
Hypothesis
The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation.
Purpose:
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
Objectives:
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Determine changes in pulse rate
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Determine changes in SpO2
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Recognize breath sound's changes possibly associated with airway blockage
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Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
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Relate the use of Isolite® with the frequency of head reposition to open the airway.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
Study Design
Outcome Measures
Primary Outcome Measures
- Isolite and Dental Treatment Under Conscious Sedation [120 minutes (sedation appointment time)]
In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam. Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).
Secondary Outcome Measures
- Isolite and Dental Treatment Under Conscious Sedation [120 minutes (sedation appointment)]
Finally, it is important to recognize that this is a pilot study with limitations, including: A small number of participants No group control Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated. Conclusions: The results of this pilot study suggest the following conclusions: Isolite ® may be safely used during pediatric dental treatment under conscious sedation. The successful use of Isolite ® is related to the patient's behavior. The weakness aspect of Isolite ® is the soft bite block that allows the youngest patients to chew on it. Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
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4-7 years of age
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Patients English and Spanish speaking
Exclusion Criteria:
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Upper airway infection
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Craniofacial anomalies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas Health Science Center-Dental School | San Antonio | Texas | United States | 78229 |
| 2 | University of Texas Health Science Center-Ricardo Salinas Dental Clinic | San Antonio | Texas | United States | 78237 |
Sponsors and Collaborators
- The University of Texas Health Science Center at San Antonio
Investigators
- Principal Investigator: Claudia I Contreras, DDS, University of Texas
Study Documents (Full-Text)
None provided.More Information
Publications
- American Academy on Pediatrics; American Academy on Pediatric Dentistry. Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatr Dent. 2008-2009;30(7 Suppl):143-59.
- Bingham RM, Proctor LT. Airway management. Pediatr Clin North Am. 2008 Aug;55(4):873-86, ix-x. doi: 10.1016/j.pcl.2008.04.004. Review.
- Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
- Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44.
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- HSC200120233H