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Not yet recruiting NCT07062601

Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children

No phase Interventional Etomidate Esketamine Tonsillectomy Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Etomidate and fentanyl group, Etomidate and esketamine group.
Who it may be relevant to
Registry conditions: Etomidate, Esketamine, Tonsillectomy, Children. Basic parameters: 2 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children With General Anesthesia

Overview

Objective: To explore the effect of etomidate and esketamine on postoperative pain after tonsillectomy in children. Methods: Investigators enrolled 64 children with American Society of Anesthesiologists (ASA) physical status I and II, aged 2-10 years, and scheduled for elective undergoing tonsillectomy with general anesthesia. All the enrolled patients were randomly divided into etomidate and fentanyl group (Group A) and etomidate and esketamine group (Group B). In the etomidate-fentanyl group (group A), 0.3 mg/kg etomidate and 4 µg/kg fentanyl were given at the induction of anesthesia, followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the surgery, respectively; in the etomidate-esketamine group (group B), induction of anesthesia with 0.3 mg/kg etomidate and 0.5 mg/kg esketamine , followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the operation. Anesthesiologists who were unaware of the grouping recorded the FlACC Pain Scale at 2 h, 8 h, and 24 h after surgery.

Interventions

  • Drug Etomidate and fentanyl group
    In the etomidate-fentanyl group (group A), 0.3 mg/kg etomidate and 4 µg/kg fentanyl were given at the induction of anesthesia, followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the surgery, respectively.
  • Drug Etomidate and esketamine group
    In the etomidate-esketamine group (group B), induction of anesthesia with 0.3 mg/kg etomidate and 0.5 mg/kg esketamine , followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the operation

Primary outcome measures

  • The face, legs, arms, crying, consolability (FLACC) pain scale [Time frame: at 2 hours, 8 hours, and 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • Children who underwent elective tonsillectomy
  • Aged 2-10 years old
  • ASA class I-II

Exclusion criteria

  • Children with hepatic or renal dysfunction
  • Those with increased intracranial or intra-ocular pressure
  • Children with schizophrenia, bipolar disorder, and any other psychiatric condition
  • Children with preexisting chronic pain
  • Children with preoperative combined sinus bradycardia or atrioventricular block

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07062601 · Xuzhang0109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗