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RecruitingNCT07780760Updated Aug 21, 2026

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

An interventional study of Group D (dexmedetomidine group) and Group L (Lidocaine group) in Sore Throat, Dexmedetomidine Analgesia and Tonsillectomy, sponsored by Fayoum University Hospital. Recruiting at 1 site in Egypt. Open to female participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

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 Fayoum University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
3 Years to 15 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Sore Throat
  • Dexmedetomidine Analgesia
  • Tonsillectomy

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Keywords

  • Nebulized Dexmedetomidine
  • Nebulized Lidocaine
  • Tonsillectomy In Childern
03

In context

Pharyngitis Unverified

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

This study's planned enrollment of 70 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 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
3 Years to 15 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    group D (Dexmedetomidine group)

    will recieve a dose of Dexmedetomidine 1 mcg/kg

    Drug: Group D (dexmedetomidine group)

  • Active comparator
    Group L (Lidocaine group)

    will recieve Lidocaine 2%, 1 mg/kg

    Drug: Group L (Lidocaine group)

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of Postoperative Sore Throat (POST)

    Time frame: immediately on PACU

Secondary outcomes

  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).

    Time frame: at the 4th postoperative hour

  2. *Hemodynamic Parameters

    Heart Rate

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

  3. Hemodynamic Parameters

    Mean Arterial Blood Pressure

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

  4. Hemodynamic Parameters

    Oxygen Saturation ( SPO2 )

    Time frame: 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

    Time frame: during the first postoperative hour.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07780760
Lead sponsor
Fayoum University Hospital
Responsible party
Mustafa Omar Rateb Abdelhafez (Doctor, Fayoum University Hospital) — Principal investigator
First posted
Aug 21, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Mustafa Omar Rateb Abdelhafez, MBBCH
Contact
mo114@fayoum.edu.eg
01153599320 ext. +20

Oversight

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

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