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Impact of Compound Chamomile and Lidocaine Hydrochloride Gel on Postoperative Sore Throat in Children Undergoing General Anesthesia with Tracheal Intubation: A Multicenter, Randomized Controlled Trial

Impact of Compound Chamomile and Lidocaine Hydrochloride Gel on Postoperative Sore Throat in Children Undergoing General Anesthesia with Tracheal Intubation: A Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128191
Enrollment
Unknown
Registered
2026-07-15
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Postoperative Sore Throat

Interventions

Experimental group:Lubrication treatment of the tracheal tube: Use a 5 ml sterile medical syringe to withdraw 2.5 ml of Kami-gel, and apply it evenly on the surface of the cuff and on the part of the
Control group:Lubrication treatment of the tracheal tube: Use normal saline to evenly apply on the surface of the cuff, on the part of the tube 4 cm above the cuff, and on the tip of the laryngoscope.

Sponsors

Women and Children's Medical Center Affiliated to Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Age between 8 and 17 years, inclusive, regardless of gender 2.Pediatric patients scheduled for elective non-neck, non-laryngeal, and non-oropharyngeal surgery under general anesthesia with orotracheal intubation 3.American Society of Anesthesiologists (ASA) physical status class I-II 4.Anticipated duration of endotracheal tube placement >= 2 hours 5.Written informed consent obtained from the parent(s)/legal guardian(s) and assent from the child, when appropriate

Exclusion criteria

Exclusion criteria: 1.Children with oropharyngeal or cervical anatomical abnormalities 2.Children with a history of difficult airway surgery or anticipated difficult airway; 3.Children with upper respiratory tract infection within the past two weeks or any medical history accompanied by sore throat, hoarseness, cough, or sputum production; 4.Children with a history of airway hyperresponsiveness diseases (e.g., bronchial asthma, cough-variant asthma, chest tightness–variant asthma, etc.); 5.Children scheduled for neck, laryngeal, or oropharyngeal surgery; 6.Children requiring nasogastric or orogastric tube placement; 7.Children requiring postoperative mechanical ventilation; 8.Children with severe systemic diseases or conditions requiring long-term immunosuppressive therapy, such as: congenital or severe acquired cardiac disease, renal insufficiency (eGFR < 30 mL·min?¹·1.73 m?²), hepatic insufficiency (Child-Pugh class C or high MELD score), active hematologic malignancy, congenital or acquired immunodeficiency, and chronic diseases requiring long-term systemic immunosuppression/glucocorticoid therapy (e.g., systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease, ulcerative colitis, severe allergic disorders, etc.); 9.Children undergoing thoracic surgery; 10.Children with intellectual disability, psychiatric disorders, or other conditions that may hinder compliance with follow-up assessments; 11.Children with known hypersensitivity to lidocaine or any components related to chamomile (Matricaria chamomilla); 12.Children who have participated in another clinical trial within 30 days prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Postoperative Sore Throat;

Secondary

MeasureTime frame
postoperative cough;Airway reaction after extubation;Postoperative hoarseness;

Countries

China

Contacts

Public ContactSong Xingrong

Guangzhou Women and Children's Medical Center, Affiliated to Guangzhou Medical University

sxjess@126.com+86 139 2241 6303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026