Intranasal dexmedetomidine‑esketamine for pain relief after adenoid and tonsil surgery in children
Impact of Intranasal Dexmedetomidine-esketamine Administration on Postoperative Pain in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Trial
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 |
| Enrollment | 160 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07479602 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.