Postoperative Sore Throat in the Pediatric Population.

NCT03389776 | Completed

• 1 other identifier: 2276
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal tubes (ETT) and laryngeal mask airways (LMA) are devices used to help breathing whilst patients are asleep for surgery. Children may have a more satisfying experience if the rate of of post operative sore throat (POST) and hoarseness (PH) could be reduced. The incidence of POST and PH may be as high as 42% in children undergoing anesthesia. ETTs and LMAs require inflation of a cuff after insertion to obtain a seal to a patient's airway for them to be effective. It is recommended that cuff pressures are checked after insertion and inflation with a pressure checking device but this does not occur in all routine anesthetic practice. Overinflation of these cuffs may cause damage to the airway by exerting pressure on surrounding structures. Studies have shown both children and adults to have increased risk of POST with higher LMA pressure. The number of times it takes to successfully insert a LMA has also been associated with POST as has female gender and older age. Similarly to LMAs, multiple insertion attempts of ETT insertion, female gender and a larger size are more likely to cause POST and PH. Although patients with uncuffed have a higher incidence of POST than those with a cuffed ETT, when using cuffed tubes ETT, POST occurs more often as cuff pressure increases and should therefore be routinely measured. The location of a patient's sore throat may vary. It may be intermittent or constant, or described as difficulty in swallowing, painful swallowing or hoarse voice and may there may be difference locations within the throat. In the current literature there is no one definition of what constitutes a sore throat or how or when it should be measured. The hypothesis is that occurrence and severity of POST could be determined by various factors other than the pressure of the cuff alone. In particular, the pressure of cuff, the duration of anesthesia, the airway manipulations, could all be factors determining the occurrence of postoperative sore throat. Based on the above hypothesis, Investigators planed to perform a prospective cohort study. Aims: to determine the occurrence and severity of post-anaesthesia sore throat in children undergoing surgical procedures with LMA or ETT placement. If clear factors are demonstrated for POST and PH in pediatric population then measures can be taken to reduce them and thereby improve outcome and patient satisfaction.

Conditions

Anesthesia Morbidity; Sore Throat

Outcome Measures

Primary Outcomes (1)

• Occurrence of sore throat

  No pain, minimal pain, mild pain, severe pain

  Six hours after anesthesia

Secondary Outcomes (5)

• Stridor

  6 hours after anesthesia

• Laryngospasm

  6 hours after anesthesia

• Oxygen desaturation

  6 hours after anesthesia

• Time to oral intake

  6 hours after anesthesia

• Hospital discharge

  6 hours after anesthesia

Interventions

Anesthesia PROCEDURE

Occurrence and severity of postoperative sore throat could be determined by various factors other than the pressure of the cuff alone. In particular, cuff pressure measurement, duration of anaesthesia, airway manipulations e.g. multiple insertion attempts, could all be factors determining the occurrence of postoperative sore throat.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A cohort of minimum 255 children will be prospectively collected from the elective surgical lists of Great Ormond Street Hospital, London, UK. Children 5 years of age or greater, scheduled for surgical procedures will be included.

You may qualify if:

• Child age 5 or over
• General anaesthesia with LMA or ETT
• Children undergoing general, orthopaedic, urology, renal or plastic surgery

You may not qualify if:

• Other types of surgery
• Patients aged less than 5 years
• Patients affected by a significant cognitive delay
• Patients planned for anaesthesia with airway devices different from ETT and LMA

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nicola Disma, MD, PhD

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 4, 2018
• Study Start: December 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

GB (1)