Study Comparing Two Medicines to Reduce Anxiety Before Kids' Surgery
This study is comparing two different medications, intranasal dexmedetomidine and oral midazolam, to see which works better and is safer for reducing anxiety in children aged 2-10 before elective surgery.
Research Profile
Published: May 5, 2026
Added to SpecialCircle: June 19, 2026
Evidence Level
Clinical trialResearch Status
Recruiting clinical trialKey takeaways
- •The study is comparing intranasal dexmedetomidine and oral midazolam as premedication for children undergoing elective surgery.
- •Premedication helps reduce anxiety in children, makes parent-child separation easier, and improves cooperation during anesthesia induction.
- •Oral midazolam, a common premedication, has limitations, while intranasal dexmedetomidine is a promising alternative with sedative and anxiety-reducing effects.
- •The research aims to provide evidence on the effectiveness and safety of both medications to improve premedication strategies in pediatric anesthesia.
- •Children aged 2-10 years undergoing specific elective surgeries may be eligible to participate in this recruiting study.
Source
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Clinical trial registry
Read the original sourcePlain-language summary
This study, scheduled to begin in 2026, is investigating two different medications given to children aged 2 to 10 before they have elective inguinal or urological surgery. The main goal is to compare intranasal dexmedetomidine with oral midazolam to see which is more effective and safer at calming children before general anesthesia.
Giving medicine beforehand, called premedication, is really important because it helps lower a child's anxiety, makes it easier for parents to say goodbye, and helps the child cooperate when receiving anesthesia. Oral midazolam is widely used but has some drawbacks.
Intranasal dexmedetomidine, given through the nose, is being explored as a good alternative because it can calm kids and reduce anxiety with minimal effects on breathing. This study will involve randomly assigning children to receive one of these two medicines, and doctors will carefully observe how well it works for sedation, how children react, and their recovery time.
The findings are expected to help improve how children are prepared for surgery.
How it works
Science explained
Dexmedetomidine is a type of medicine known as a selective alpha-2 (α2)-adrenoreceptor agonist. This means it works by targeting specific receptors in the body that help produce a calming (sedative) effect and reduce anxiety (anxiolytic). It is also thought to have minimal effects on a child's breathing compared to some other medicines used for sedation.
Why parents may care
Parents may care about this research because it seeks to find better ways to reduce children's anxiety and discomfort before and during surgery. Improved premedication strategies could make the challenging experience of parent-child separation and anesthesia induction smoother and less stressful for their child.
What this means for daily life
If intranasal dexmedetomidine is found to be a more effective and safer option, children undergoing surgery might experience less fear and distress, potentially leading to an easier separation from parents and a calmer start to their medical procedure.
Clinical trial journey
Phase
A study comparing two existing medications to see which is better and safer for children before surgery.
Enrollment
RECRUITING
Who may be eligible
Pediatric patients aged 2-10 years who are undergoing elective inguinal and urological surgery under general anesthesia.
What is still unknown
It is still unknown whether intranasal dexmedetomidine is more effective and safer than oral midazolam for reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. This study aims to provide clinically relevant evidence to compare these two options.
Frequently asked questions about Special Needs General
This study is comparing two medications, intranasal dexmedetomidine and oral midazolam, used to calm children aged 2-10 before they have elective inguinal or urological surgery. It aims to see which is more effective and safer for reducing anxiety.
Terminology glossary
- Premedication
- Medicine given before a medical procedure, like surgery, to help a patient relax and reduce anxiety.
- Midazolam
- A common medication often given by mouth to children to help them relax before surgery, though it can sometimes have variable effects.
- Dexmedetomidine
- A medication that can be given through the nose to calm and reduce anxiety, being studied as a potential alternative for children before surgery.
- Anxiolytic
- A substance or medication that helps to reduce or relieve anxiety.
- Sedative
- A substance or medication that causes a calming or sleep-inducing effect.
- Randomized, double-blind, controlled study
- A type of research where participants are randomly assigned to groups, and neither the patients nor the doctors know who is getting which treatment, to ensure a fair comparison.
Questions to ask your doctor or therapist
- ?What premedication options are available for my child before their surgery?
- ?What are the potential benefits and risks of the different premedication choices for my child?
- ?How can I help my child prepare for their surgery to reduce their anxiety?
- ?Are there any clinical trials for pediatric premedication that my child might be eligible for?
⚕️ This research digest is for educational and community support purposes only. It is not medical advice, diagnosis, or treatment. Always speak with a qualified doctor, therapist, or medical professional before making decisions about care.
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