Intranasal dexmedetomidine‑esketamine for pain relief after adenoid and tonsil surgery in children
Official title: Impact of Intranasal Dexmedetomidine-esketamine Administration on Postoperative Pain in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Trial
Run by Peking University First Hospital · NCT07479602 · Data updated 2026-11-12
This trial will test whether giving children aged 3–7 a combined dexmedetomidine and esketamine nasal dose reduces pain after adenoid and tonsil surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 7, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07479602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3–7 scheduled for adenoidectomy and/or tonsillectomy who can safely receive intranasal medication and whose guardians can give consent.
✕Probably not a fit
Children with nasal disease, significant heart or lung problems, severe developmental or sensory impairments, abnormal liver or kidney tests, ASA class ≥ III, obesity above the 95th percentile, or allergies to dexmedetomidine or esketamine are unlikely to qualify or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 3–7 scheduled for adenoidectomy and/or tonsillectomy will receive either intranasal dexmedetomidine‑esketamine or an intranasal saline placebo and be followed for postoperative pain and recovery measures. The combination is chosen because dexmedetomidine and esketamine provide complementary sedation and analgesia while minimizing respiratory depression, and intranasal delivery avoids injections. Key outcomes include pain scores and analgesic use in the first two postoperative days and rates of return to hospital for pain or dehydration. Standard exclusions apply for nasal disease, significant cardiopulmonary conditions, major developmental or sensory impairments, abnormal liver/kidney function, high anesthesia risk, obesity, or drug allergy.
Why it matters
Potential benefit: If successful, this could reduce severe postoperative pain and lower the need for opioid pain medicines in young children after adenoid and tonsil surgery.
How similar studies have gone: Previous pediatric work has shown dexmedetomidine and esketamine separately can provide sedation and analgesia and reduce opioid needs, but combined intranasal use for this surgery is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: 01083572784
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy
This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.
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Dexmedetomidine and esketamine given around surgery to improve recovery after general anesthesia
This trial will test whether giving dexmedetomidine, esketamine, or both during the perioperative period helps adults recover better after surgery under general anesthesia.
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Remimazolam, dexmedetomidine, or esketamine to calm young children before surgery
This trial will test which of three drugs—remimazolam, dexmedetomidine, or esketamine—best calms children aged 2–5 before adenotonsillectomy and reduces postoperative agitation.
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Comparing dexmedetomidine and bupivacaine for pain management after brain surgery
This study is testing if adding dexmedetomidine to bupivacaine can help reduce pain better after brain surgery compared to using bupivacaine alone.
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Combining dexmedetomidine and esketamine to improve sleep after major surgery
This study is testing whether a mix of two medications, dexmedetomidine and esketamine, can help adults sleep better after major surgery compared to a placebo.
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Using dexmedetomidine and esketamine for sedation in young children before surgery
This study tests if a combination of two medications, dexmedetomidine and esketamine, can help young children feel calm and relaxed before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.