AdenotonsillectomyPhase 4NCT07479602
Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients
A Phase 4 study testing Intranasal dexmedetomidine-esketamine in people with Adenotonsillectomy and Children, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Adenotonsillectomy, Children, Intranasal Administration
- What is being tested?
- Intranasal dexmedetomidine-esketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to Feb 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 3-7 years old.
- Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.
- Provides written informed consent by the guardian.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ting Ding, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PhD, 01083572784, wangdongxin@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Adenotonsillectomy, Children, Intranasal Administration, Dexmedetomidine, Esketamine, Postoperative Pain
- Being tested
- Intranasal dexmedetomidine-esketamine, Intranasal placebo (normal saline)
- Keywords
- Adenotonsillectomy, Children, Intranasal administration, Dexmedetomidine, Esketamine, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidine-esketamineDrug
A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.
Intranasal placebo (normal saline)Drug
Placebo (normal saline) will administered intranasally after anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dexmedetomidine-esketamine combination will be administered intranasally after anesthesia induction. Receives: Drug: Intranasal dexmedetomidine-esketamine |
| Control group | Placebo comparator | Placebo (normal saline) will be administered intranasally after anesthesia induction. Receives: Drug: Intranasal placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of pain intensity within 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.
Measured: Up to 48 hours after surgery
Secondary outcomes (2)
Sleep quality during the first three nights 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.
Measured: Up to three days after surgery
Cumulative consumption of analgesics within 48 hours
Cumulative consumption of analgesics within 48 hours after surgery.
Measured: Up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start7 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479602
- Sponsor's protocol ID
- 2026-0115
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stanko D, Bergesio R, Davies K, Hegarty M, von Ungern-Sternberg BS. Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up. Paediatr Anaesth. 2013 Aug;23(8):690-6. doi: 10.1111/pan.12170. Epub 2013 May 13.
PubMed 23668258Brown KA, Laferriere A, Lakheeram I, Moss IR. Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates. Anesthesiology. 2006 Oct;105(4):665-9. doi: 10.1097/00000542-200610000-00009.
PubMed 17006062Tan L, Carachi P, Anderson BJ. The time course of pain after tonsillectomy. Paediatr Anaesth. 2020 Sep;30(9):1051-1053. doi: 10.1111/pan.13970. Epub 2020 Aug 6. No abstract available.
PubMed 32666587Postier AC, Chambers C, Watson D, Schulz C, Friedrichsdorf SJ. A descriptive analysis of pediatric post-tonsillectomy pain and recovery outcomes over a 10-day recovery period from 2 randomized, controlled trials. Pain Rep. 2020 Mar 6;5(2):e819. doi: 10.1097/PR9.0000000000000819. eCollection 2020 Mar-Apr.
PubMed 32440612Levin M, Seligman NL, Hardy H, Mohajeri S, Maclean JA. Pediatric pre-tonsillectomy education programs: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Jul;122:6-11. doi: 10.1016/j.ijporl.2019.03.024. Epub 2019 Mar 22.
PubMed 30921630Lima LACN, Otis A, Balram S, Giasson AB, Carnevale FA, Frigon C, Brown KA. Parents' perspective on recovery at home following adenotonsillectomy: a prospective single-centre qualitative analysis. Can J Anaesth. 2023 Jul;70(7):1202-1215. doi: 10.1007/s12630-023-02479-2. Epub 2023 May 9.
PubMed 37160822Stewart DW, Ragg PG, Sheppard S, Chalkiadis GA. The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair. Paediatr Anaesth. 2012 Feb;22(2):136-43. doi: 10.1111/j.1460-9592.2011.03713.x. Epub 2011 Oct 25.
PubMed 22023485Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.
PubMed 24330523Liu F, Kong F, Zhong L, Wang Y, Xia Z, Wu J. Preoperative Esketamine Alleviates Postoperative Pain after Endoscopic Plasma Adenotonsillectomy in Children. Clin Med Res. 2023 Jun;21(2):79-86. doi: 10.3121/cmr.2023.1818.
PubMed 37407213Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917.
PubMed 30921525