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Completed

NCT Number: NCT03140228

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

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.

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Key information

Conditions

Laryngeal Masks Anesthesia Infections Minors Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

I-gel

Device

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.

LMA

Device

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.

Primary outcomes

  1. Frequency and severity of postoperative sore throat

    Time frame: 24 hours

    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.

    • Postoperative Sore Throat: Constant pain or discomfort in the throat which is independent of swallowing postoperatively for 24 hours.
    • Severity of Sore throat: The severity of sore throat will be measured by a four-point categorical pain scale.

    Grading of severity is as follow:

    0 = no sore throat

    • mild (complains of sore throat only on asking)
    • moderate (complains of sore throat on his/her own)
    • severe (change of voice or hoarseness, associated with throat pain).

    Chi-square test will be applied to compare frequency and severity of post-operative sore throat between two groups. P ≤ 0.05 will be considered as significant.

Secondary outcomes

  1. Immediate complications

    Time frame: Immediately after removal of supraglottic device

    Frequency will be calculated for immediate complications which includes laryngospasm, stridor, coughing, aspiration etc.

  2. Insertion time

    Time frame: 5 minutes

    time of insertion of supraglottic device

  3. Ease of insertion

    Time frame: 5 minutes

    Ease of insertion

  4. Total number of attempts

    Time frame: 5 minutes

    maximum three attempts

  5. Oropharyngeal seal pressure

    Time frame: 5 minutes

    seal pressure

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Aug 2, 2019

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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