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Completed

NCT Number: NCT03197753

Postoperative Discomfort After Dental General Anesthesia

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Keles

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laryngeal mask airway

Device

Laryngeal mask airway

Nasotracheal intubation

Device

Nasotracheal intubation

Primary outcomes

  1. Postoperative discomfort

    Time frame: Postoperative 1 hour

    Sore throat

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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