Postoperative Discomfort After Dental General Anesthesia

Postoperative Pain Clinical Trial

Official title:

Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197753
• Other study ID #: 2017/011
• Status: Completed
• Phase: N/A
• First received: June 22, 2017
• Last updated: August 15, 2017
• Start date: June 15, 2017
• Est. completion date: August 4, 2017

Study information

• Verified date: August 2017
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 4, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Laryngeal mask airway
Laryngeal mask airway
• Nasotracheal intubation
Nasotracheal intubation

Locations

Country	Name	City	State
Turkey	Sultan Keles	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative discomfort	Sore throat	Postoperative 1 hour