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Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

RecruitingPhase 4Ages 3 Years - 7 YearsAllPeking University First Hospital
NCT07479602 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intranasal dexmedetomidine-esketamine
  • Intranasal placebo (normal saline)
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Where

1 site
Peking University First Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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