Postoperative Discomfort After Dental General Anesthesia

• Sponsor: Aydin Adnan Menderes University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03197753
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 42.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Device: Laryngeal mask airway; Device: Nasotracheal intubation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: ParallelParallel
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes assessor
• Primary Purpose: Prevention
• Official Title: Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway
• Actual Study Start Date: Jun 15, 2017
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laryngeal mask airway Laryngeal mask airway insertion	Device: Laryngeal mask airway; Laryngeal mask airway
Active Comparator: Nasotracheal intubation Nasotracheal tube insertion	Device: Nasotracheal intubation; Nasotracheal intubation

Outcome Measures

Primary Outcome Measures

1. Postoperative discomfort [Postoperative 1 hour]

   Sore throat

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan Keles	Aydın	Efeler	Turkey	09100

Sponsors and Collaborators

• Aydin Adnan Menderes University

Investigators

• Principal Investigator: Sultan KELES, Dr., Aydin Adnan Menderes University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: SULTAN KELES, Assist. Prof.Dr., Aydin Adnan Menderes University
• ClinicalTrials.gov Identifier: NCT03197753
• Other Study ID Numbers: 2017/011
• First Posted: Jun 23, 2017
• Last Update Posted: Aug 17, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SULTAN KELES, Assist. Prof.Dr., Aydin Adnan Menderes University: laryngeal mask airway; nasotracheal intubation; dental treatment
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Aug 17, 2017