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Clinical Trials/NCT03197753
NCT03197753CompletedNot Applicable

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

Aydin Adnan Menderes University1 site in 1 country70 target enrollmentStarted: June 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Postoperative discomfort

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Outcomes assessor

Eligibility Criteria

Ages
3 Years to 7 Years (Child)
Sex
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.

Arms & Interventions

Laryngeal mask airway

Experimental

Laryngeal mask airway insertion

Intervention: Laryngeal mask airway (Device)

Nasotracheal intubation

Active Comparator

Nasotracheal tube insertion

Intervention: Nasotracheal intubation (Device)

Outcomes

Primary Outcomes

Postoperative discomfort

Time Frame: Postoperative 1 hour

Sore throat

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

SULTAN KELES

Assist. Prof.Dr.

Aydin Adnan Menderes University

Study Sites (1)

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