Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients

NCT07479602 | Recruiting Phase 4 DMC

• 1 other identifier: 2026-0115
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 48 hours after surgery

Secondary Outcomes (2)

• Sleep quality during the first three nights after surgery

  Up to three days after surgery

• Cumulative consumption of analgesics within 48 hours

  Up to 48 hours after surgery

Other Outcomes (5)

• Time to extubation after surgery

  Up to 2 hours after surgery

• Length of stay in PACU

  Up to 24 hours after surgery

• Incidence of adverse events during PACU stay

  Up to 24 hours after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Dexmedetomidine-esketamine combination will be administered intranasally after anesthesia induction.

Drug: Intranasal dexmedetomidine-esketamine

Control group

PLACEBO COMPARATOR

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

Drug: Intranasal placebo (normal saline)

Interventions

Intranasal dexmedetomidine-esketamine DRUG

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

Intervention group

Intranasal placebo (normal saline) DRUG

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

Control group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 3-7 years old.
• Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.
• Provides written informed consent by the guardian.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 23668258 BACKGROUND

• Brown 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.

  PMID: 17006062 BACKGROUND

• Tan 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.

  PMID: 32666587 BACKGROUND

• Postier 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.

  PMID: 32440612 BACKGROUND

• Levin 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.

  PMID: 30921630 BACKGROUND

• Lima 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.

  PMID: 37160822 BACKGROUND

• Stewart 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.

  PMID: 22023485 BACKGROUND

• Dorkham 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.

  PMID: 24330523 BACKGROUND

• Liu 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.

  PMID: 37407213 BACKGROUND

• Mitchell 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.

  PMID: 30921525 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

01083572784; wangdongxin@hotmail.com

Ting Ding, MD

CONTACT

athena_d@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 18, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)