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NCT Number: NCT07062601

Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate and fentanyl group

Drug

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.

Etomidate and esketamine group

Drug

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 outcomes

  1. The face, legs, arms, crying, consolability (FLACC) pain scale

    Time frame: at 2 hours, 8 hours, and 24 hours after surgery

    Anesthesiologists who were unaware of the grouping recorded the face, legs, arms, crying, consolability (FLACC) pain scale at 2 hours, 8 hours, and 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Anqing Municipal Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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