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Effect of intranasal Dexmedetomidine-Esketamine Combination on Postoperative Pain after Tonsillectomy and/or Adenoidectomy in Children : A Single CenterDouble-BlindRandomized Clinical Trial

Effect of intranasal Dexmedetomidine-Esketamine Combination on Postoperative Pain after Tonsillectomy and/or Adenoidectomy in Children : A Single CenterDouble-BlindRandomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085642
Enrollment
Unknown
Registered
2024-06-14
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Perioperative Pain

Interventions

placebo group:An appropriate amount of normal saline was injected into the patients nose 30min before anesthesia induction
Dexmedetomidine group:Before 30 minutes anesthesia induction,2ug/kg of dexmedetomidine was injected into the patients nose.
Dexmedetomidine combined with esketamine group:Before 30 minutes anesthesia induction,1 ug/kg of dexmedetomidine and 0.6 mg/kg of esketamine was injected into the patients nose.

Sponsors

Xuzhou Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) Age 2 ~ 7 years old; (2) American Society of Anesthesiology (ASA) physical status (I&II); (3) patients undergoing tonsillectomy and/or adenoidectomy;

Exclusion criteria

Exclusion criteria: (1) The child or his/her parents refused to participate in the study; (2) Participated in other clinical trials within 4 weeks before enrollment; (3) History of long-term use of narcotics or taking esketamine; (4) Allergy to dexmedetomidine or esketamine; (5) weight greater than the 95th percentile of that age and sex; (6) Known cardiopulmonary disease (such as uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumor or structural lung disease); (7) Mental retardation or vision and hearing problems that cause inability to communicate; (8) Children with intraocular pressure and intracranial hypertension; (9) Children with electrocardiogram showing conduction block and sick sinus syndrome; (10) Family history of mental illness, etc.;

Design outcomes

Primary

MeasureTime frame
Pain scores;

Secondary

MeasureTime frame
Induction ComplianceChecklist;PAED score;Ramsay Sedation score;recovery time;Time of Removing the endotracheal tube;Anxiety scores;Score of sedation during awakening;Time of stay in the PACU;Remifentanil consumption;Analgesic consumption;Intraoperative blood pressure;Intraoperative heart rate;Pre-induction sedation score;Incidence of adverse events;Incidence of sleep disturbances;Pain score at three months postoperatively;

Countries

China

Contacts

Public ContactZhang Yueying, Li Li

Xuzhou Children's Hospital

zyy0218@126.com+86 180 5226 8602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026