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Impact of Intranasal Dexmedetomidine-esketamine Administration on Postoperative Pain in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 7
Healthy Volunteers: f
View:

• Aged 3-7 years old.

• Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.

• Provides written informed consent by the guardian.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-Xin Wang, MD, PhD
wangdongxin@hotmail.com
01083572784
Backup
Ting Ding, MD
athena_d@sina.com
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2027-02
Participants
Target number of participants: 160
Treatments
Experimental: Intervention group
Dexmedetomidine-esketamine combination will be administered intranasally after anesthesia induction.
Placebo_comparator: Control group
Placebo (normal saline) will be administered intranasally after anesthesia induction.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov