Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

April 8, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Dexmedetomidine-esketamine combination will be administered intranasally after anesthesia induction.
Drug: Intranasal dexmedetomidine-esketamine
A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.
Placebo Comparator: Control group
Placebo (normal saline) will be administered intranasally after anesthesia induction.
Drug: Intranasal placebo (normal saline)
Placebo (normal saline) will administered intranasally after anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve of pain intensity within 48 hours after surgery
Time Frame: Up to 48 hours after surgery
Pain 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.
Up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality during the first three nights after surgery
Time Frame: Up to three days after surgery
Sleep 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.
Up to three days after surgery
Cumulative consumption of analgesics within 48 hours
Time Frame: Up to 48 hours after surgery
Cumulative consumption of analgesics within 48 hours after surgery.
Up to 48 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to extubation after surgery
Time Frame: Up to 2 hours after surgery
Time to extubation at the end of surgery.
Up to 2 hours after surgery
Length of stay in PACU
Time Frame: Up to 24 hours after surgery
Length of stay in PACU after surgery.
Up to 24 hours after surgery
Incidence of adverse events during PACU stay
Time Frame: Up to 24 hours after surgery
Adverse events are defined as any events that required intervention during PACU stay, including laryngospasm, bronchospasm, airway obstruction, nausea and vomiting, desaturation (pulse oxygen saturation <90%), bradycardia (heart rate <60 beats per minute), bleeding, and others.
Up to 24 hours after surgery
Length of stay in hospital after surgery
Time Frame: Up to 30 days after surgery
Length of stay in hospital after surgery.
Up to 30 days after surgery
Incidence of complications within 30 days after surgery
Time Frame: Up to 30 days after surgery
Postoperative complications are defined as new-onset condition that are deemed harmful and required therateutic intervention, i.e., class II or higher on the Clavien-Dindo classification.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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