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Sore ThroatNCT07780760

Effect of Preoprative Nebulized Dexmedetomidine Compared to Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy In Childern.

A study testing Group D (dexmedetomidine group) and Group L (Lidocaine group) in people with Sore Throat and Dexmedetomidine Analgesia, run by Fayoum University Hospital at 1 site in Egypt.

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Sites and contacts
Official record

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Trial summary

The aim of the study is to compare the effect of nebulized Dexmedetomidine compared to nebulized Lidocaine on postoperative sore throat in childern undergoing Tonsillectomy. Read more about this study

Who is it for?
Ages 3 to 15 years, women only
What is being tested?
Group D (dexmedetomidine group) and Group L (Lidocaine group)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
1 Sep 2026to 1 Feb 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 15 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Age: Childern between 3:15 years old
  • American Society of Anesthesiologists(ASA) Physical Status I or II
  • Elective Tonsillectomy

Who cannot join

  • Parents refusal
  • Presence of preoperative sore throat
  • Known allergy to the study drug
  • History of upper respiratory tract infection 2 weeks prior to surgery
  • Mental retardation or inability to communicate
  • Significant Cardiovascular disease as Heart Block
  • Post Tonsillectomy bleeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mustafa Omar Rateb Abdelhafez, MBBCH contact

01153599320 ext. +20

mo114@fayoum.edu.eg

Egypt1 site, 1 recruiting
  • Fayoum university Hospitl

    Al Fayyum

    Mustafa Omar Rateb Abdelhafez, MBBCH, 01557486122 ext. +20, mo1205@fayoum.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Preoprative Nebulized Dexmedetomidine Compared to Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy In Childern. A Prospective, Randomized, Double-Blinded Trial.

The aim of the study is to compare the effect of nebulized Dexmedetomidine compared to nebulized Lidocaine on postoperative sore throat in childern undergoing Tonsillectomy.

Read the detailed description

Tonsillectomy is one of the most commonly performed day-case surgeries in pediatric patients. Despite its routine nature, post operative sore throat (POST) remains significant cause of morbidity, leading to discomfort and reduced parental satisfaction(1) POST ranked sixth among the 10 most undesirable adverse effects related to general anesthesia (2). Irritation and inflammation of the airway caused by pressure exerted on the tracheal wall by the endotracheal tube (ETT)(3) trauma during intubation and mucosal dehydration(4) are thought to be the mechanistic basis for a postoperative sore throat (POST) During tonsillectomy, the shared surgical and anesthetic field poses a risk of airway manipulation, necessitating close cooperation between surgeon and anesthesiologist to maintain adequate oxygenation and a clear operative field(5) Intraoperative blood or fluid aspiration can further exacerbate upper airway irritation, contributing to POST(6) Given the impact of POST on patient well-being, effective preventive strategies are essential for optimizing postoperative recovery (7) Nebulization therapy is widely used to prevent POST. It is highly recommended because of small volume of drugs required for effect, easy way of administration, better patient compliance, and most importantly little risk of adverse events compared with other methods(such as gargle, intravenous, etc.)(8) Commonly used aerosolized drugs include corticosteroids, ketamine, magnesium, lidocaine, Non-steroidal anti-inflammatory drugs(NSAIDs), etc. and have achieved various effects(9_12) Previous studies showed promising results for both Nebulized Dexmedetomidine and Nebulized Lidocaine in Attenuating Sore Throat(13_14) , yet no study has directly compared the efficacy of Nebulized Dexmedetomidine Versus Nebulized Lidocaine in Attenuating Sore Throat Following Tonsillectomy.

Being tested
Group D (dexmedetomidine group), Group L (Lidocaine group)
Keywords
Nebulized Dexmedetomidine, Nebulized Lidocaine, Tonsillectomy In Childern
Medical subject headings
Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group D (dexmedetomidine group)Drug

    group D (Dexmedetomidine group) will recieve a dose of 1 mcg/kg

  • Group L (Lidocaine group)Drug

    will recieve Lidocaine 2%, 1 mg/kg

Study groups in NCT07780760
Study groupRoleWhat they receive
group D (Dexmedetomidine group)Experimentalwill recieve a dose of Dexmedetomidine 1 mcg/kg
Receives: Drug: Group D (dexmedetomidine group)
Group L (Lidocaine group)Active comparatorwill recieve Lidocaine 2%, 1 mg/kg
Receives: Drug: Group L (Lidocaine group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Postoperative Sore Throat (POST)

    Measured: immediately on PACU

Secondary outcomes (5)
  1. Severity of sore throat (ST)

    specifically at the 4th postoperative hour. ST was scored on a four-point scale (0-3) (20) 0 =No ST

    1. =mild ST (complains of ST only on asking);
    2. =moderate ST (complains of ST on his/her own)
    3. =severe ST (change in voice or hoarseness, associated with throat pain).

    Measured: at the 4th postoperative hour

  2. *Hemodynamic Parameters

    Heart Rate

    Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively

  3. Hemodynamic Parameters

    Mean Arterial Blood Pressure

    Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively

  4. Hemodynamic Parameters

    Oxygen Saturation ( SPO2 )

    Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively

  5. evaluation of other adverse effects

    such as nausea, vomiting and cough

    Measured: during the first postoperative hour.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780760
Sponsor's protocol ID
M932
Status last verified
Aug 2026
First submitted
15 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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