S-ketamin Premedication in Pediatric EENT Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Different Premedication in Pediatric Patients

NCT04266340

Agitation

COMPLETED NA

Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

NCT01065701

Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital

COMPLETED PHASE3

Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.

NCT07180095

Sedation Preoperative Anxiety Experienced by the Pediatric Patient Anxiolytic Effect +1 more

NOT_YET_RECRUITING PHASE1/PHASE2

A Comparative Evaluation of Nebulized Dexmedetomidine and Nebulized Ketamine as a Premedication in Pediatric Surgeries

NCT05719506

Anesthesia Refusal

COMPLETED PHASE4

Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery

NCT04485273

Emergence Agitation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group.

The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia Emergence Delirium \[PAED\] scale) and POV was assessed in the postanesthetic care unit (PACU). Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and patients' satisfaction degree were also assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotions Separation Anxiety Pain, Procedural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Jiangsu Hengrui Medicine Co.,Ltd. Jiangsu Hengrui Medicine Co.,Ltd. Jiangsu Hengrui Medicine Co.,Ltd. Jiangsu Hengrui Medicine Co.,Ltd. Jiangsu Hengrui Medicine Co.,Ltd.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study.

Exclusion Criteria

* Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No