NCT03140228

Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.

Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel® in Children Undergoing Elective Lower Abdominal or Orthopedic Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is rated as 8th most undesirable outcome in postoperative period.It not only affects the patient's satisfaction but also can affect patient activities after leaving hospital. Many factors can contribute to postoperative sore throat and the incidence has been found to vary with the method by which airway is managed. The study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The study will be done in children who are able to self-report the severity of sore throat. This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA) is better in terms of causing less complication spells of sore throat. The use of such device will not only reduce the severity and frequency of postoperative sore throat that may affect the activities of patient after leaving hospital but also will improve satisfaction level of patient and parents.

Detailed description

OBJECTIVE: The objective of our study is to assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA) and I-gel in children undergoing elective lower abdominal or orthopedic surgery. HYPOTHESIS: Use of I-gel in children undergoing elective lower abdominal or orthopedic surgery is associated with decrease frequency and severity of postoperative sore throat as compared to use of AuraOnce Laryngeal Mask Airway.

Conditions

• Laryngeal Masks
• Pharyngitis
• Minors
• Anesthesia

Interventions

Type	Name	Description
DEVICE	I-Gel	I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.
DEVICE	LMA	The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-08-15
• Completion: 2017-09-01
• First posted: 2017-05-04
• Last updated: 2019-08-02

Locations

1 site across 1 country: Pakistan