Intranasal dexmedetomidine-esketamine: A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.
Intranasal placebo (normal saline): Placebo (normal saline) will administered intranasally after anesthesia induction.
Study summary
Postoperative pain after adenoid and tonsil surgery is significant, with approximately 75% of pediatric patients experiencing severe postoperative pain. Currently, there is a lack of clinical strategies to safely and effectively manage postoperative pain in children undergoing adenoid and tonsil surgery. Dexmedetomidine and esketamine can achieve appropriate sedation levels and alleviate postoperative pain when used in children. Both drugs can be administered intranasally, and their pharmacological effects complement each other, reducing side effects. This study aims to investigate whether intranasal administration of dexmedetomidine-esketamine combination can improve postoperative analgesia in children undergoing adenoid and tonsil surgery.
Eligibility
Sex
ALL
Min age
3 Years
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 3-7 years old.
* Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.
* Provides written informed consent by the guardian.
Exclusion Criteria:
* Unsuitable for intranasal administration due to nasal diseases (such as rhinitis, nasal polyps, or any condition causing nasal congestion).
* Clearly diagnosed cardiovascular and respiratory diseases.
* Communication barriers due to delayed neurological development or visual or hearing impairments.
* Traumatic brain injury or neurosurgery.
* Abnormal liver and kidney function (biomarkers higher than twice of the upper normal limits).
* Amercian Society of Anesthesiologists classification ≥ III.
* Body mass index higher than the 95th percentile of the age- and sex-standardized references.
* Allergic to dexmedetomidine and/or esketamine.
* Any other conditions that are deemed unsuitable for study participation.
Primary outcome measure(s)
Area under curve of pain intensity within 48 hours after surgery — Up to 48 hours after surgery Pain intensity will be assessed with the Face, Legs, Activity, Cry, Consolability scale (FLACC; scores range from 0 to 10, with higher scores indicating more severe pain intensity) at 10, 20, an 30 minutes after entering the post-anesthesia care unit (PACU), at 3 and 6 hours after surgery, and then twice daily (8:00-10:00 am, 6:00-8:00 pm) until 48 hours after surgery.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.