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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07780760
Enrollment
70
Registered
2026-08-21
Start date
2026-09-01
Completion date
2027-02-01
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine Analgesia, Sore Throat, Tonsillectomy

Keywords

Nebulized Dexmedetomidine, Nebulized Lidocaine, Tonsillectomy In Childern

Brief 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.

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.

Interventions

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

DRUGGroup L (Lidocaine group)

will recieve Lidocaine 2%, 1 mg/kg

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
3 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of Postoperative Sore Throat (POST)immediately on PACU

Secondary

MeasureTime frameDescription
Severity of sore throat (ST)at the 4th postoperative hourspecifically 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).
*Hemodynamic Parametersevery 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperativelyHeart Rate
Hemodynamic Parametersevery 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperativelyMean Arterial Blood Pressure
evaluation of other adverse effectsduring the first postoperative hour.such as nausea, vomiting and cough

Countries

Egypt

Contacts

CONTACTMustafa Omar Rateb Abdelhafez, MBBCH
mo114@fayoum.edu.eg01153599320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026