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.
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
- Conditions the study is for
- Sore Throat, Dexmedetomidine Analgesia, Tonsillectomy
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum university Hospitl
Al Fayyum
Mustafa Omar Rateb Abdelhafez, MBBCH, 01557486122 ext. +20, mo1205@fayoum.edu.eg
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.
- Conditions
- Sore Throat, Dexmedetomidine Analgesia, 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 group | Role | What they receive |
|---|---|---|
| group D (Dexmedetomidine group) | Experimental | will recieve a dose of Dexmedetomidine 1 mcg/kg Receives: Drug: Group D (dexmedetomidine group) |
| Group L (Lidocaine group) | Active comparator | will 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.
Incidence of Postoperative Sore Throat (POST)
Measured: immediately on PACU
Secondary outcomes (5)
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
- =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).
Measured: at the 4th postoperative hour
*Hemodynamic Parameters
Heart Rate
Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively
Hemodynamic Parameters
Mean Arterial Blood Pressure
Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively
Hemodynamic Parameters
Oxygen Saturation ( SPO2 )
Measured: every 5 minutes intraoperatively and at 0,1,3,6,12 and 24hrs postoperatively
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.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Omar Rateb Abdelhafez, Fayoum University Hospital
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