Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up.
Dana Stanko, Ric Bergesio, Kylie Davies...
https://pubmed.ncbi.nlm.nih.gov/23668258Actively Recruiting
Phase 4
Age: 3Years - 7Years
All Genders
ID07479602
Impact of Intranasal Dexmedetomidine-esketamine on Postoperative Pain in Children Undergoing Adenotonsillectomy: A Randomized Placebo-Controlled Trial
Led by Peking University First Hospital · Updated on 2026-04-09
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 treatment's 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 other’s 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
Who Can Participate
Age: 3Years - 7Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 3-7 years old
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
D
Dong-Xin Wang, MD, PhD
T
Ting Ding, MD
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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Published Research Related To This Trial
Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates.
Karen A Brown, André Laferrière, Indrani Lakheeram...
https://pubmed.ncbi.nlm.nih.gov/17006062The time course of pain after tonsillectomy.
Lena Tan, Peter Carachi, Brian J Anderson
https://pubmed.ncbi.nlm.nih.gov/32666587A descriptive analysis of pediatric post-tonsillectomy pain and recovery outcomes over a 10-day recovery period from 2 randomized, controlled trials.
Andrea C Postier, Christine Chambers, David Watson...
https://pubmed.ncbi.nlm.nih.gov/32440612Pediatric pre-tonsillectomy education programs: A systematic review.
Marc Levin, Nicole L Seligman, Heather Hardy...
https://pubmed.ncbi.nlm.nih.gov/30921630Parents' perspective on recovery at home following adenotonsillectomy: a prospective single-centre qualitative analysis.
Laura A C N Lima, Annik Otis, Sharmila Balram...
https://pubmed.ncbi.nlm.nih.gov/37160822The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair.
David W Stewart, Philip G Ragg, Suzette Sheppard...
https://pubmed.ncbi.nlm.nih.gov/22023485Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions.
Mariana C Dorkham, George A Chalkiadis, Britta S von Ungern Sternberg...
https://pubmed.ncbi.nlm.nih.gov/24330523Preoperative Esketamine Alleviates Postoperative Pain after Endoscopic Plasma Adenotonsillectomy in Children.
Feng Liu, Fanli Kong, Liang Zhong...
https://pubmed.ncbi.nlm.nih.gov/37407213Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary.
Ron B Mitchell, Sanford M Archer, Stacey L Ishman...
https://pubmed.ncbi.nlm.nih.gov/30921525