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

Aga Khan University

Status

Completed

Conditions

Laryngeal Masks

Pharyngitis

Minors

Anesthesia

Treatments

Device: LMA

Device: I-Gel

Study type

Interventional

Funder types

Other

Identifiers

NCT03140228

4249-Ane-ERC-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

6 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

6 to 16 year old patients of both gender
ASA (American Society of Anesthesiologists) I and ASA II patients
Scheduled for elective lower abdominal surgery (inguinal hernia repair or circumcision) or orthopedic surgery (upper and lower limb) under General anesthesia.

Exclusion criteria

Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status)
Difficult airway(difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass)
Children who are unable to self-report pain using a four-point categorical pain scale
Refusal of the parent
Refusal of the child to give assent
Patients having pre-existing sore throat or symptoms of Upper respiratory tract infection.
Obese children i.e. BMI for age percentile equal to or greater than the 95th percentile on BMI-for-age percentile growth charts.