Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients (NCT07479602) | Clinical Trial Compass
RecruitingPhase 4
Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients
China160 participantsStarted 2026-04-07
Plain-language 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.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under curve of pain intensity within 48 hours after surgery