RecruitingPhase 4NCT07479602

Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

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


Sponsor

Peking University First Hospital

Enrollment

160 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 7 Years

Inclusion Criteria3

  • Aged 3-7 years old.
  • Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.
  • Provides written informed consent by the guardian.

Exclusion Criteria9

  • 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.

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Interventions

DRUGIntranasal dexmedetomidine-esketamine

A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.

DRUGIntranasal placebo (normal saline)

Placebo (normal saline) will administered intranasally after anesthesia induction.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT07479602


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