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New treatment option for Behavior Problem
Official title Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
ClinicalTrials.gov ID: NCT06579937
What this study is testing
What is Esketamine hydrochloride?
Esketamine hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for behavior problem.
Also referred to as esketamine hydrochloride injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 7
You may be able to join if
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
You likely can't join if
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index \> 30 kg/m2;
- Allergy to study drugs;
See the full eligibility criteria
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index \> 30 kg/m2;
- Allergy to study drugs;
- Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- Any other conditions that precluded study inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.