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CompletedNCT03389776POSTUpdated Aug 8, 2019

Postoperative Sore Throat in the Pediatric Population.

An observational study in Anesthesia Morbidity and Sore Throat, sponsored by Istituto Giannina Gaslini. Completed at 1 site in United Kingdom. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Istituto Giannina Gaslini · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
197
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

The study is a prospective, descriptive study, involving patient interview and objective data collected as part of routine anesthetic care. No intervention will take place. Once identified from a theatre list, patients/parents will be approached preoperatively and consent taken to participate. If inclusion criteria are met and consent gained the preoperative questionnaire will be completed to obtain information regarding pain, nausea, sore throat, itching, thirst and hunger. Each symptom will be graded none, mild, moderate, severe. Intraoperative data will be collected after surgery whilst the child is in the recovery room. This is objective data obtained from the anesthetic chart. Prior to discharge to the ward the child will undergo a second interview answering the same questions as he/she did preoperatively (a further 1-2 minutes). Any child who has a sore throat in the recovery room will then be followed up 2 hours later on the ward with a further questionnaire. This will include questions about the location of the sore throat, severity and voice changes (5-10 mins). This will be the end of the participants input.

02

Conditions studied

  • Anesthesia Morbidity
  • Sore Throat

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03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 197 is below the median of 289 across 33 observational studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
197 participants (actual)
Patient registry
No

Interventions

  • ProcedureAnesthesia

    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.

06

What researchers measure

Primary outcomes

  1. Occurrence of sore throat

    No pain, minimal pain, mild pain, severe pain

    Time frame: Six hours after anesthesia

Secondary outcomes

  1. Stridor

    Y/N

    Time frame: 6 hours after anesthesia

  2. Laryngospasm

    Y/N

    Time frame: 6 hours after anesthesia

  3. Oxygen desaturation

    Y/N

    Time frame: 6 hours after anesthesia

  4. Time to oral intake

    Hours

    Time frame: 6 hours after anesthesia

  5. Hospital discharge

    Hours

    Time frame: 6 hours after anesthesia

07

Study locations

1 site
  • Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03389776
Lead sponsor
Istituto Giannina Gaslini
Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Responsible party
Nicola Disma, MD (Nicola Disma, MD, PhD, Istituto Giannina Gaslini) — Principal investigator
First posted
Jan 4, 2018
Start date
Dec 1, 2017
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Last update
Aug 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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