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The effect of intraoperative dexmedetomidine-esketamine intranasal administration on postoperative pain in pediatric patients undergoing adenotonsillectomy: a randomized, double-blind, placebo-controlled study

The effect of intraoperative dexmedetomidine-esketamine intranasal administration on postoperative pain in pediatric patients undergoing adenotonsillectomy: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121444
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive sleep-disordered breathing, oSDB

Interventions

active drug group:Inhalation of dexmedetomidine + esketamine
placebo group:Inhale an equal amount of normal saline

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Age: 3 - 7 years old 2.The patient is scheduled to undergo adenoidectomy and tonsillectomy (or simple tonsillectomy) under general anesthesia 3.The guardian has signed the informed consent form

Exclusion criteria

Exclusion criteria: 1.Due to nasal diseases (such as rhinitis, nasal polyps, or any condition causing nasal congestion), nasal administration is not suitable 2.Children have diagnosed cardiovascular and respiratory diseases 3.Children have delayed neurological development or have visual or hearing impairments affecting communication 4.Post-traumatic brain injury or after neurosurgery 5.Abnormal liver and kidney function (more than twice the upper limit of normal values) 6.ASA classification = III 7.The child's BMI is above the 95th percentile of the age and gender standard 8.Allergic to dexmedetomidine and/or esketamine, or other situations deemed by the researchers not suitable for inclusion in the study

Design outcomes

Primary

MeasureTime frame
The FLACC score within 48 hours after the operation;

Secondary

MeasureTime frame
Postoperative hospital stay;PACU residence time;The incidence of adverse events during the stay in the PACU;Postoperative analgesic drugs;PACU residence time;The incidence of complications 30 days after the surgery;The NRS scores for sleep during the first three nights after the surgery;Postoperative extubation time;

Countries

China

Contacts

Public ContactDing Ting

Peking University First Hospital

athena_d@sina.com+86 137 1880 3529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026