Back to resultsPostoperative Discomfort After Dental General Anesthesia
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laryngeal mask airway
Nasotracheal intubation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring laryngeal mask airway, nasotracheal intubation, dental treatment
Eligibility Criteria
Inclusion Criteria:
- Aged 3-7 years,
- ASA I and II
- Lack of chairside cooperation for dental treatment in clinical setting.
Exclusion Criteria:
- A history of of anticipated difficult entubation ,
- Patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease,
- When the expected dental procedure was more than two hours
- Mental retardation and those whose parents did not consent to their participation in the study.
Sites / Locations
- Sultan Keles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laryngeal mask airway
Nasotracheal intubation
Arm Description
Laryngeal mask airway insertion
Nasotracheal tube insertion
Outcomes
Primary Outcome Measures
Postoperative discomfort
Sore throat
Secondary Outcome Measures
Full Information
NCT ID
NCT03197753
First Posted
June 22, 2017
Last Updated
August 15, 2017
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT03197753
Brief Title
Postoperative Discomfort After Dental General Anesthesia
Official Title
Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this prospective, randomised, controlled clinical trial was to compare immediate postoperative discomfort, emergence delirium and recovery time of the patients intubated using either laryngeal mask airway or nasotracheal intubation.
Detailed Description
A total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under general anesthesia. Children were randomly grouped into Laryngeal mask airway (LMA) group (n=35) and nasotracheal intubation (NTI) groups (n=35). In LMA group LMA was inserted after anesthesia induction using 8% sevoflurane. In NTI group rocuronium and remifentanil were given intravenously during %8 sevoflurane induction and the patients were intubated by a nasotracheal tube. After completion of the dental treatments patients were transferred to the post anesthesia care unit (PACU). Duration of dental operation ,duration of anesthesia, recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laryngeal mask airway, nasotracheal intubation, dental treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
Outcomes Assessor
Masking Description
Outcomes assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laryngeal mask airway
Arm Type
Experimental
Arm Description
Laryngeal mask airway insertion
Arm Title
Nasotracheal intubation
Arm Type
Active Comparator
Arm Description
Nasotracheal tube insertion
Intervention Type
Device
Intervention Name(s)
Laryngeal mask airway
Intervention Description
Laryngeal mask airway
Intervention Type
Device
Intervention Name(s)
Nasotracheal intubation
Intervention Description
Nasotracheal intubation
Primary Outcome Measure Information:
Title
Postoperative discomfort
Description
Sore throat
Time Frame
Postoperative 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 3-7 years,
ASA I and II
Lack of chairside cooperation for dental treatment in clinical setting.
Exclusion Criteria:
A history of of anticipated difficult entubation ,
Patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease,
When the expected dental procedure was more than two hours
Mental retardation and those whose parents did not consent to their participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan KELES, Dr.
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Keles
City
Aydın
State/Province
Efeler
ZIP/Postal Code
09100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16295223
Citation
Hung WT, Chen CC, Chau MY, Tsai WY. Effect of reinforced laryngeal mask airway or endotracheal intubation anesthesia on adverse events: quality of life issues for dental patients requiring general sedation. Spec Care Dentist. 2005 Jul-Aug;25(4):188-92. doi: 10.1111/j.1754-4505.2005.tb01648.x.
Results Reference
background
PubMed Identifier
24820727
Citation
Zhao N, Deng F, Yu C. Anesthesia for pediatric day-case dental surgery: a study comparing the classic laryngeal mask airway with nasal trachea intubation. J Craniofac Surg. 2014 May;25(3):e245-8. doi: 10.1097/SCS.0000000000000547.
Results Reference
background
Learn more about this trial
Postoperative Discomfort After Dental General Anesthesia
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