Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children

NCT07062601 | Not Yet Recruiting

• 1 other identifier: Xuzhang0109
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Etomidate; Esketamine; Tonsillectomy; Children

Keywords

Etomidate; Esketomine; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

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

  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

  at 2 hours, 8 hours, and 24 hours after surgery

Study Arms (2)

Etomidate and fentanyl group

EXPERIMENTAL

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 fentanyl group

Etomidate and esketamine group

EXPERIMENTAL

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

Drug: Etomidate and esketamine group

Interventions

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 fentanyl group

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

Etomidate and esketamine group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

MeSH Terms

Interventions

Etomidate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 14, 2025
• Study Start: July 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 15, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-06