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NCT Number: NCT07780760

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

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.

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Key information

Age range

3 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum university Hospitl

Al Fayyum, Egypt

Location status: Recruiting

Location contact

Mustafa Omar Rateb Abdelhafez, MBBCH

CONTACT

[email protected]

01557486122 ext. +20

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Incidence of Postoperative Sore Throat (POST)

    Time frame: immediately on PACU

Secondary outcomes

  1. Severity of sore throat (ST)

    Time frame: at the 4th postoperative hour

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

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

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

    Heart Rate

  3. Hemodynamic Parameters

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

    Mean Arterial Blood Pressure

  4. Hemodynamic Parameters

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

    Oxygen Saturation ( SPO2 )

  5. evaluation of other adverse effects

    Time frame: during the first postoperative hour.

    such as nausea, vomiting and cough

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa Omar Rateb Abdelhafez, MBBCH

CONTACT

[email protected]

01153599320 ext. +20

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

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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