EtomidateNCT07062601
Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children
A study testing Etomidate and fentanyl group and Etomidate and esketamine group in people with Etomidate and Esketamine, run by Anqing Municipal Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Etomidate, Esketamine, Tonsillectomy
- What is being tested?
- Etomidate and fentanyl group and Etomidate and esketamine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who underwent elective tonsillectomy
- Aged 2-10 years old
- ASA class I-II
Who cannot join
- 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
About this study
Official title: Effect of Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children With General Anesthesia
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
- Being tested
- Etomidate and fentanyl group, Etomidate and esketamine group
- Keywords
- Etomidate, Esketomine, Tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etomidate and fentanyl groupDrug
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 groupDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Etomidate and esketamine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2 hours, 8 hours, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EtomidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062601
- Sponsor's protocol ID
- Xuzhang0109
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children With General Anesthesia
- ClinicalTrials.gov ID
- NCT07062601
- Acronym / sponsor ID
- Xuzhang0109
- Conditions
- Etomidate, Esketamine, Tonsillectomy, Children
- Keywords
- Etomidate, Esketomine, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate and fentanyl group | Experimental | Drug: Etomidate and fentanyl groupIn 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 | Experimental | Drug: Etomidate and esketamine groupIn 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 |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who underwent elective tonsillectomy
- Aged 2-10 years old
- ASA class I-II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etomidate and fentanyl groupIn 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 groupIn 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 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate and fentanyl group and Etomidate and esketamine group in people with Etomidate and Esketamine, run by Anqing Municipal Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The face, legs, arms, crying, consolability (FLACC) pain scale (time frame: at 2 hours, 8 hours, and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.