Postoperative Discomfort After Dental General Anesthesia
Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jun 2017
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2017
CompletedFirst Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2017
CompletedAugust 17, 2017
August 1, 2017
2 months
June 22, 2017
August 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative discomfort
Sore throat
Postoperative 1 hour
Study Arms (2)
Laryngeal mask airway
EXPERIMENTALLaryngeal mask airway insertion
Nasotracheal intubation
ACTIVE COMPARATORNasotracheal tube insertion
Interventions
Eligibility Criteria
You may qualify if:
- Aged 3-7 years,
- ASA I and II
- Lack of chairside cooperation for dental treatment in clinical setting.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Keles
Aydin, Efeler, 09100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 16295223BACKGROUNDZhao 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.
PMID: 24820727BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sultan KELES, Dr.
Aydin Adnan Menderes University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof.Dr.
Study Record Dates
First Submitted
June 22, 2017
First Posted
June 23, 2017
Study Start
June 15, 2017
Primary Completion
August 1, 2017
Study Completion
August 4, 2017
Last Updated
August 17, 2017
Record last verified: 2017-08