Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 3 to 7

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.

More Postoperative Pain trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages3 Years to 7 Years
SexAll
Enrollment160 (estimated)
SponsorPeking University First Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedApril 7, 2026
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedApril 9, 2026
Trial IDNCT07479602 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.