Study of Intranasal Dexmedetomidine and Esketamine for Pain Relief After Adenoid and Tonsil Surgery in Children Aged 3 to 7
Led by Peking University First Hospital · Updated on 2026-04-09
160
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Postoperative pain after adenoid and tonsil surgery is a significant problem for children, with about 75% experiencing severe pain. This trial studies whether a combination of two drugs, dexmedetomidine and esketamine, given through the nose can improve pain relief in children aged 3 to 7 undergoing these surgeries. The study is randomized and placebo-controlled to carefully evaluate the treatments effects.
The trial involves two groups one receives an intranasal combination of dexmedetomidine and esketamine after anesthesia, and the other receives a placebo of normal saline in the same way. These drugs are chosen because they complement each others effects and may reduce side effects. The study tests whether this combination can provide better pain control after surgery compared to placebo.
Participants will be monitored for pain intensity for up to 48 hours after surgery, with assessments including the area under the curve of pain scores. Sleep quality during the first three nights and the total amount of pain medication used within 48 hours will also be recorded. The study includes careful monitoring of participants and lasts through the early postoperative period to evaluate the effectiveness and safety of the treatment.
CONDITIONS
Brief Title
Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients
Research Team
D
Dong-Xin Wang, MD, PhD
T
Ting Ding, MD
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Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia
Provides written informed consent by the guardian
You will not qualify if you...
Unsuitable for intranasal administration due to nasal diseases such as rhinitis, nasal polyps, or nasal congestion
Diagnosed cardiovascular or respiratory diseases
Communication barriers due to delayed neurological development or visual or hearing impairments
History of traumatic brain injury or neurosurgery
Abnormal liver or kidney function with biomarkers higher than twice the normal limits
American Society of Anesthesiologists classification of III or higher
Body mass index above the 95th percentile for age and sex
Allergy to dexmedetomidine or esketamine
Any other condition deemed unsuitable for study participation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day
Participants receive intranasal dexmedetomidine-esketamine or placebo after anesthesia induction during surgery.
1 visit (in-person on surgery day)
Post-operative Follow-up
Duration - Up to 3 days after surgery
Participants are monitored for postoperative pain and sleep quality for up to 3 days after surgery.
Approximately 3 follow-up visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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