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Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

Impact of Intranasal Dexmedetomidine-esketamine Administration on Postoperative Pain in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07479602
Enrollment
160
Registered
2026-03-18
Start date
2026-04-07
Completion date
2027-02-01
Last updated
2026-04-09

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

Conditions

Adenotonsillectomy, Children, Dexmedetomidine, Esketamine, Intranasal Administration, Postoperative Pain

Keywords

Adenotonsillectomy, Children, Intranasal administration, Dexmedetomidine, Esketamine, Postoperative pain

Brief summary

Postoperative pain after adenoid and tonsil surgery is significant, with approximately 75% of pediatric patients experiencing severe postoperative pain. Currently, there is a lack of clinical strategies to safely and effectively manage postoperative pain in children undergoing adenoid and tonsil surgery. Dexmedetomidine and esketamine can achieve appropriate sedation levels and alleviate postoperative pain when used in children. Both drugs can be administered intranasally, and their pharmacological effects complement each other, reducing side effects. This study aims to investigate whether intranasal administration of dexmedetomidine-esketamine combination can improve postoperative analgesia in children undergoing adenoid and tonsil surgery.

Detailed description

Adenoid and tonsil surgery is a common surgical intervention for obstructive sleep-disordered breathing and is one of the most frequently performed surgeries in pediatric patients. The operation lasts approximately 45 minutes but is associated with significant postoperative pain; about 75% of children experiencing severe postoperative pain, which can affect swallowing and may cause psychological distress in children. About 12-16% of children return to hospital after discharge due to pain or dehydration. Postoperative analgesia during the initial two days is often inadequate. Currently, clinicians have explored various strategies to effectively manage postoperative pain after adenoid and tonsil surgery in children, but the results are unreliable and have multiple side effects. Dexmedetomidine is a highly selective α2 receptor agonist with anxiolytic, sedative, and analgesic effects, and has a minimal impact on respiration at low doses. When used as an adjuvant analgesic after surgery, it improves analgesia, reduces opioid consumption, and decreases opioid-related adverse events. Dexmdetomidine is also used in pediatric patients but may produce bradycardia and hypotension at routine doses. Ketamine is a non-competitive N-Methyl-D-aspartic acid (NMDA) receptor antagonist and has been used as an anesthetic and analgesic for decades. Esketamine is the S-enantiomer of ketamine and has an analgesic potent of approximately 2 times of that of ketamine. Esketamine is also used in children but may produce neuropsychiatric side effects. Dexmedetomidine and esketamine can each be administered intranasally. When used in combination, the sympathomimetic activity of esketamine may counteract the bradycardic and hypotensive effects of dexmedetomidine, and the sedative effect of dexmedetomidine can mitigate the neuropstchiatric side effects of esketamine. Intranasal administration of dexmedetomidine-esketamine combination has been used for preoperative sedation in children and may improve postoperative analgesia after adenoid and tonsil surgery. However, the success rate and efficacy of intranasal dexmedetomidine-esketamine are difficult to guarantee in preschool children due to poor cooperation and intranasal secretions. This randomized trial is designed to test the hypothesis that intranasal administration of dexmedetomidine-esketamine combination after anesthesia intubation may improve postoperative analgesia in children undergoing adenoid and tonsil surgery.

Interventions

DRUGIntranasal dexmedetomidine-esketamine

A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.

DRUGIntranasal placebo (normal saline)

Placebo (normal saline) will administered intranasally after anesthesia induction.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Area under curve of pain intensity within 48 hours after surgeryUp to 48 hours after surgeryPain intensity will be assessed with the Face, Legs, Activity, Cry, Consolability scale (FLACC; scores range from 0 to 10, with higher scores indicating more severe pain intensity) at 10, 20, an 30 minutes after entering the post-anesthesia care unit (PACU), at 3 and 6 hours after surgery, and then twice daily (8:00-10:00 am, 6:00-8:00 pm) until 48 hours after surgery.

Secondary

MeasureTime frameDescription
Sleep quality during the first three nights after surgeryUp to three days after surgerySleep quality will be assessed by the guardians using the numeric rating scale (NRS; a 0-10 scale where 0=the best sleep and 10=the worst sleep) in the first three morning (8:00-10:00 am) after surgery.
Cumulative consumption of analgesics within 48 hoursUp to 48 hours after surgeryCumulative consumption of analgesics within 48 hours after surgery.

Countries

China

Contacts

CONTACTDong-Xin Wang, MD, PhD
wangdongxin@hotmail.com01083572784
CONTACTTing Ding, MD
athena_d@sina.com
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD

Peking University First Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026